Description:FIELD OF THE INVENTION

[001] The present disclosure generally relates to methods of capsule manufacturing, and more particularly, the present disclosure relates to a method for conditioning a surface of a first portion of a capsule.

BACKGROUND

[002] Capsules are used for holding ingredients in a sealed environment, thereby protecting the ingredients therein. Capsules are known to be of two types, namely, hard capsules, and soft gel capsules. Typically, the soft gel capsules are manufactured by making a soft gel layer using a hot layer and a soft capsule layer. The soft gel layer is pressed over a dosage form and then sealed to deliver an encapsulated dosage.

[003] On the other hand, the hard capsules have a strong structure and are suitable for high-volume and high-speed production. The hard capsules are, generally, separately filled and then closed, thereby allowing for secure holding of ingredients in the enclosed environment. As such, the hard capsules require different machinery for separation, filling, and reassembly thereof. The hard capsules, available worldwide, are manufactured by the aforementioned manufacturing process in various sizes to accommodate various dosage volumes and a variety of dosage formats. However, the major drawback of the hard capsules is their inability to be sealed properly.

[004] Conventionally, various processes have been devised for the enclosing of the hard capsules. The hard capsules include an upper body and a lower body which are joined together by various techniques. Typical hard capsules include a specifically engineered air gap and structures between the upper body and the lower body. The structures are adapted to assist in the venting of pressure created within an enclosed chamber. The pressure is created as the upper body is telescoped over the lower body and an available volume is compressed downwards, as part of the enclosure and locking process. Without these structures, the high-speed manufactured enclosure of commercially available capsules may become inefficient and unreliable over a period of time.

[005] Conventional enclosing methods applied to the hard capsules may lead to various problems, including problems in maintaining quality of ingredients and dosages due to the ingress of oxygen and resultant oxidation of sensitive ingredients due to the presence of the abovementioned venting structures.

[006] In addition, the hard capsules may contain liquid ingredients which may tend to leak out of gap(s) that are present in the venting structures between the upper body and the lower body. Ingredients may also include sensitive ingredients, for example, probiotics, which are highly susceptible to moisture ingress through these structures in un-sealed capsules. Alternatively, a few sensitive ingredients may require a high moisture environment and a conventional enclosure may result in the dehydration of ingredients resulting in loss of efficacy thereof. Leakage of liquid ingredients, the oxidation of most ingredients or damage of ingredients due to change in moisture levels may have major repercussions for capsule manufacturers, resulting in poor customer experience, reputational injury, cost inefficiency, and even rejection of large batches of capsules, market withdrawal of defective product and potential problems with industry regulators, all substantially increasing costs for both manufacturers and brand owners of the capsules.

[007] To overcome the abovementioned problems, manufacturers employ methods of sealing the hard capsules. All conventional methods involve the application of a sealant to the capsule after enclosure. This may include band sealing, spraying, coating, etc. The most common sealing methodology is the application of a “band seal” of liquid gelatine to a ridgeline between the upper body and the lower body of the hard capsule. The hard capsule is rolled over a roller coated with liquid gelatine, and then a thin layer of gelatine is applied to an outside of the overlapping area of the upper body and the lower body. The gelatine layer is then air-dried to create a seal.

[008] During spraying, a layer of a sealant is applied on an exterior of the capsule body, specifically in the overlapping area of the upper body and the lower body. During coating, the capsule may be fully sealed from the outside with a sealant layer. However, due to the coating of the whole capsule, the sealant layer may delay release of the ingredients, and may only find use in instances where such delay is desired.

[009] The abovementioned sealing of an external surface of the enclosed capsule is advantageous as it allows the manufacturers to apply large volumes of sealant to the upper portion and the lower portion which may be subsequently sealed with high levels of airflow and temperature. There is a limited requirement for precise engineering and dosing of the capsule in such a case. This method may however expose the seal to external conditions and forces, due to which the capsule may experience high levels of production failure. Further, production rates are low as it takes time for the sealant to dry and may not work with all applications such as 3-part capsules.

[0010] It is therefore advantageous to apply the method of internal application of the sealant between the upper body and the lower body prior to enclosure. For such internal application, the sealant may be applied on an inner side of the upper body or an exterior side of the lower body. The upper body and the lower body may then be enclosed. In doing so, both the upper body and the lower body are exposed to the sealant, thereby forming a seal between them. A few examples of existing prior art related to the sealing of the capsule in this arrangement and the technical difficulties related thereto shall now be explained briefly in the upcoming paragraphs.

[0011] US4403461 describes the challenges of mechanical scraping of the sealant from the inside of a capsule: “the adhesive is deposited inside the cap within a well-defined zone relatively distant from the edge of this cap, so that during fitting together, this adhesive tends to be pushed back inside the capsule and cannot, in any case, ooze out.” The referenced patent application further deals with the surplus pressure created from the compression of the internal volume between upper and lower bodies as the upper body is telescoped over the lower body during enclosure. US4403461 attempts to seal a capsule under a vacuum in order to limit the outward venting effect. However, in the absence of a complete vacuum, the venting will still occur. Further, setting the sealant permanently requires time, thereby leading to a delay in withdrawing the vacuum. If the vacuum is withdrawn before the sealant is permanently set, the lower internal pressure in the enclosed volume created by the vacuum will result in inward venting of unsealed space and the sealant and the ingredients of the capsule may be drawn out of the capsule during the venting. Therefore, the method suggested by the referenced patent application is slow, and includes highly technical manufacturing techniques, alongside producing a capsule that has a low internal pressure resulting in a likely failure of the capsule post-production.

[0012] US20110088355 describes pressure build-up due to recapping of the capsule, and the resultant venting. The referenced patent application focuses on a pressure venting component of a recapping station aimed at serving to relieve pressure created by recapping.

[0013] US20100212261 also discloses pressure build-up created by the recapping of the capsule. The referenced patent application mentions that “if the gas inside the capsule is under pressure, this may cause defects to occur in the applied band during or after the application of the banding liquid, as a result of gas escaping from the inside of the capsules at the junction with the cap. This induced gas flow leads to the formation of channels from the inside of the capsule to the outside and is observed for example through the formation of bubbles in the applied band at the junction of the banded capsule.” The patent application mainly aims at providing gases of differing temperatures aimed at mitigating the pressure build-up created through the recapping.

[0014] Enclosure performed by either telescoping of a cap over the capsule body or the insertion of a membrane inside the capsule body undergoes the compression of the air volume within the enclosed cavity resulting in a pressure build-up in this cavity. The pressure will look to equalize with the outer environment through the venting between the two capsule portions. The venting of pressure in turn pushes the liquid sealant out of the desired sealing area, which usually happens by creating linear channels of airflow between the capsule portions where venting has occurred. In doing so, the seal may be compromised. Further, modern high-speed filling machines and high-volume production environments generate higher pressures due to the fast individual manufacturing rates of the enclosure.

[0015] In addition, the above-mentioned conventional methods for sealing the capsules may make the capsule prone to mechanical disassembly and tampering, thereby leaving the ingredients available for overuse, substance abuse, etc., and may further carry risks of non-compliance with clinical trials. Regulatory exceptions, non-compliance notices, harm to industry reputation, and severe legal actions may be potential consequences of the same.

[0016] Therefore, the capsules are required to be efficiently sealed with high integrity for delivering dosages. Further, the capsules are required to be leak-free, oxidization free, and strong for standing strong against the rigors of manufacturing, transportation, and for use and treatment by consumers.

SUMMARY

[0017] This summary is provided to introduce a selection of concepts, in a simplified format, that are further described in the detailed description of the invention. This summary is neither intended to identify key or essential inventive concepts of the invention nor intended for determining the scope of the invention.

Disclosed herein is a method for conditioning the surface of a first portion of a capsule. The method includes positioning the first portion of the capsule to engage the surface of the first portion with a dosing head of a sealant dispenser. A predetermined amount of a sealant is circumferentially applied onto the surface by the dosing head. The sealant is adapted to be drawn into a space between the surface of the first portion and the surface of the dosing head. The dosing head is adapted to dwell in an area of the sealant dosed onto the first portion for a predetermined dwell time ranging between 2 seconds to 5 seconds.

[0018] In one or more embodiments, the predetermined amount of the sealant is in the range of 0.19 µl to 0.81 µl per millimetre diameter of the first portion. If the quantity of a sealant dosed is more than the predetermined amount, more than a desired amount of the sealant will be left as an excessive residue moisture on the first portion. Further, an inadequate amount of the sealant may not be able to make a bond at all or may make a weak bond.

[0019] In one or more embodiments, the sealant is applied onto the surface with a predetermined dosing height ranging from 2 mm to 5 mm, and a predetermined dosing coverage ranging from 0.012 µl per mm2 to 0.130 µl per mm2. The predetermined dosing height and the predetermined dosing coverage of the sealant between the first portion and the second portion that are in contact with one another, are crucial factors, which help in managing a linear extent of the seal formed.

[0020] In one or more embodiments, the sealant includes a solvent prepared by mixing water in a range of 5% to 30% by volume, with ethanol in a range of 70% to 95% by volume.

[0021] In one or more embodiments, on the application of the sealant, the first portion undergoes conditioning.

[0022] In one or more embodiments, the method includes closing the capsule after the conditioning of the first portion, by positioning the second portion telescopically onto the first portion. A surface of the second portion is concentrically positioned onto the surface of the first portion conditioned with the sealant. The surface of the second portion fuses with the surface of the first portion due to the conditioning and absorption of the sealant into the second portion. As used herein, the term “conditioning” of the first portion refers to a partial softening of the surface of the first portion due to an introduction of moisture through the sealant. The moisture renders the first portion pliable and adhesive due to application of the sealant thereon.

[0023] In one or more embodiments, the surface of the first portion includes either an internal surface of the first portion, or an external surface of the first portion.

[0024] In one or more embodiments, the surface of the second portion includes either an internal surface of the second portion, or an external surface of the second portion.

[0025] In one or more embodiments, a geometrical profile of the dosing head of the sealant dispenser depends on a shape of the first portion, and a desired location of the sealant to be applied to the surface of the first portion.

[0026] The method disclosed herein helps in preventing the forced leaking of the sealant during the closing of the capsule. The method further helps in preventing mechanical scraping and disruption to the sealant layer while the dosing head is being lifted from the first portion after the application of the sealant on the surface of the first portion. Further, conditioning of the first portion by the method disclosed herein ensures forming of a fused bond which protects the ingredients of the capsule from leakage when the capsule is closed after conditioning of the first portion.

[0027] To further clarify advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof, which is illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] These and other features, aspects, and advantages of the present invention will become better understood when the following detailed description is read with reference to the accompanying drawings in which like characters represent like parts throughout the drawings, wherein:

[0029] Figure 1 illustrates a block diagram depicting a method for conditioning a surface of a first portion of a capsule, according to an embodiment of the present disclosure;

[0030] Figure 2a illustrates a schematic diagram depicting conditioning of an internal surface of the first portion of the capsule having a single compartment, according to an embodiment of the present disclosure;

[0031] Figure 2b illustrates a schematic diagram depicting a conditioned internal surface of the first portion of the capsule having the single compartment, according to an embodiment of the present disclosure;

[0032] Figure 3a illustrates a schematic diagram depicting conditioning of an external surface of the first portion of the capsule having a single compartment, according to an embodiment of the present disclosure;

[0033] Figure 3b illustrates a schematic diagram depicting a conditioned external surface of the first portion of the capsule having the single compartment, according to an embodiment of the present disclosure;

[0034] Figure 4a illustrates the process of dosing the sealant onto an inner surface of the first portion, such that the first portion is a cap of the capsule, according to an embodiment of the present disclosure;

[0035] Figure 4b illustrates a conditioned inner surface of the first portion, such that the first portion is the cap of the capsule, according to an embodiment of the present disclosure;

[0036] Figure 5a illustrates a schematic diagram depicting the process of dosing the sealant onto an external surface of the first portion and the second portion of the capsule having two compartments, according to an embodiment of the present disclosure;

[0037] Figure 5b illustrates a schematic diagram depicting a conditioned external surface of the compartment of the capsule having the two compartments, such that the first portion is the body of the capsule, according to an embodiment of the present disclosure;

[0038] Figure 5c illustrates a schematic diagram depicting the sealant between an internal surface of the compartment and an external surface of a membrane of the capsule having the two compartments, according to an embodiment of the present disclosure; and

[0039] Figure 5d illustrates a schematic diagram depicting a combination of a conditioned external surface of the capsule body and a conditioned external surface of the membrane of the capsule having the two compartments, according to an embodiment of the present disclosure.

[0040] Further, skilled artisans will appreciate that elements in the drawings are illustrated for simplicity and may not have necessarily been drawn to scale. Furthermore, in terms of the construction of the device, one or more components of the device may have been represented in the drawings by conventional symbols, and the drawings may show only those specific details that are pertinent to understanding the embodiments of the present invention so as not to obscure the drawings with details that will be readily apparent to those of ordinary skill in the art having benefit of the description herein.

DETAILED DESCRIPTION OF FIGURES

[0041] For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skilled in the art to which this invention belongs. The system, methods, and examples provided herein are illustrative only and not intended to be limiting.

[0042] For example, the term “some” as used herein may be understood as “none” or “one” or “more than one” or “all.” Therefore, the terms “none,” “one,” “more than one,” “more than one, but not all” or “all” would fall under the definition of “some.” It should be appreciated by a person skilled in the art that the terminology and structure employed herein is for describing, teaching, and illuminating some embodiments and their specific features and elements and therefore, should not be construed to limit, restrict, or reduce the spirit and scope of the present disclosure in any way.

[0043] For example, any terms used herein such as, “includes,” “comprises,” “has,” “consists,” and similar grammatical variants do not specify an exact limitation or restriction, and certainly do not exclude the possible addition of one or more features or elements, unless otherwise stated. Further, such terms must not be taken to exclude the possible removal of one or more of the listed features and elements, unless otherwise stated, for example, by using the limiting language including, but not limited to, “must comprise” or “needs to include.”

[0044] Whether or not a certain feature or element was limited to being used only once, it may still be referred to as “one or more features” or “one or more elements” or “at least one feature” or “at least one element.” Furthermore, the use of the terms “one or more” or “at least one” feature or element do not preclude there being none of that feature or element, unless otherwise specified by limiting language including, but not limited to, “there needs to be one or more…” or “one or more elements is required.”

[0045] Unless otherwise defined, all terms and especially any technical and/or scientific terms, used herein may be taken to have the same meaning as commonly understood by a person ordinarily skilled in the art.

[0046] Reference is made herein to some “embodiments.” It should be understood that an embodiment is an example of a possible implementation of any features and/or elements of the present disclosure. Some embodiments have been described for the purpose of explaining one or more of the potential ways in which the specific features and/or elements of the proposed disclosure fulfil the requirements of uniqueness, utility, and non-obviousness.

[0047] Use of the phrases and/or terms including, but not limited to, “a first embodiment,” “a further embodiment,” “an alternate embodiment,” “one embodiment,” “an embodiment,” “multiple embodiments,” “some embodiments,” “other embodiments,” “further embodiment”, “furthermore embodiment”, “additional embodiment” or other variants thereof do not necessarily refer to the same embodiments. Unless otherwise specified, one or more particular features and/or elements described in connection with one or more embodiments may be found in one embodiment, or may be found in more than one embodiment, or may be found in all embodiments, or may be found in no embodiments. Although one or more features and/or elements may be described herein in the context of only a single embodiment, or in the context of more than one embodiment, or in the context of all embodiments, the features and/or elements may instead be provided separately or in any appropriate combination or not at all. Conversely, any features and/or elements described in the context of separate embodiments may alternatively be realized as existing together in the context of a single embodiment.

[0048] Any particular and all details set forth herein are used in the context of some embodiments and therefore should not necessarily be taken as limiting factors to the proposed disclosure.

[0049] Embodiments of the present invention will be described below in detail with reference to the accompanying drawings.

[0050] The present disclosure relates to a method of application of a sealant on a first portion of a capsule, before a second portion of the capsule is telescopically engaged with the first portion, such that the second portion overlaps a portion of the first portion which has been conditioned by the application of the sealant. Specifically, the present disclosure relates to a pre-closure application of sealant onto the first portion of the capsule. As used herein, “pre-closure” refers to a time before the first portion is closed by the second portion.

[0051] Conventionally, the pre-closure application of the sealant to seal the capsule holds numerous challenges. For instance, during the pre-closure application of the sealant, only a predetermined amount of the sealant must be dosed onto the first portion. Once closed, the sealant dosed on the first portion will be covered from all sides, thereby losing the ability to be externally heated or dried. Consequentially, if an unspecific amount of the sealant is dosed onto the first portion, either the sealant would be too less in the amount, or excessive in the amount. In a scenario where the amount of sealant is too less in the amount, the sealant may not be able to form a strong and continuous bond between the first portion and the second portion.

[0052] In a scenario where the amount of sealant is excessive, the sealant may leave behind a high level of residual moisture, given that this moisture has nowhere to go but interact with the capsule portions. Due to the hydroscopic nature of capsule materials, the excess moisture renders the capsule material soft and pliable, thereby affecting the integrity of the capsule, and ultimately resulting in capsule failure.

[0053] The amount of the sealant being applied to the first portion is controlled, thereby preventing application of the sealant in the excessive amount, as there may be a possibility that the sealant in the excessive amount may also leak during the closing of the capsule. Only an amount of the sealant sufficient for conditioning the first portion is dosed by a dosing head of a sealant dispenser.

[0054] Once the first portion is conditioned thoroughly, only then is the dosing head lifted upwards, thereby preventing mechanical scraping of the sealant layer deposited on the first portion, by the dosing head whilst it is being lifted. Further, conditioning of the first portion and closing the first portion with the second portion fuses both the first portion and the second portion with a bond efficient enough to protect the ingredients of the capsule from leakage when the capsule is closed post-conditioning of the first portion.

[0055] In one embodiment, the first portion may be any portion of the capsule on which the sealant may be dosed. For example, the first portion may be a body (lower portion) of the capsule, the sealant may be dosed onto a surface of the body, as depicted in Figures 2a-3b, and Figures 5a-5d. In such a scenario, the second portion 416 (as shown in Figures 5a-5d) will be a cap (upper portion) of the capsule, which is telescoped onto the first portion 202 after conditioning of the first portion 202 with the sealant. In another embodiment, the first portion 202 may be the cap, as the sealant may be dosed onto a surface 204 of the cap, as shown in Figures 4a and 4b. In such a scenario, the second portion will be the body of the capsule, on which the conditioned first portion 204-A (cap) may be telescoped after conditioning of the first portion 202 with the sealant.

[0056] The method shall now be explained in detail with reference to Figures 1-3b. Specifically, Figure 1 illustrates a block diagram depicting a method 100 for sealing a capsule. In one embodiment, the capsule may include a first portion 202 and a second portion 416 (the second portion has been depicted in Figure 5d with referral numeral 416 and the same is applicable for description of all the Figures), as depicted in Figures 2a-3b. Specifically, Figure 2a illustrates a schematic diagram 200 depicting conditioning of an internal surface 204 of the first portion 202 of the capsule having a double compartment after the insertion of membrane 408, and Figure 2b illustrates a schematic diagram 300 depicting a conditioned internal surface 204-A of the first portion 202 of the capsule having the double compartment. Specifically, Figure 3a illustrates a schematic diagram 400 depicting conditioning of an external surface 212 of the first portion 202 of the capsule having a single compartment, and Figure 3b illustrates a schematic diagram 500 depicting a conditioned external surface 212-A of the first portion 202 of the capsule having the single compartment.

[0057] In one example, the first portion 202 and the second portion may be made up of, but is not limited to, animal products, fish products, a vegetable gelatine material, cellulose such as HPMC (hydroxypropyl methylcellulose or Hypromellose), and polymers. The material used in manufacturing the first portion 202 and the second portion 416 may initially be in a crystalline form, as the capsules are manufactured through a dipping or forming process that is reconstituted.

[0058] The method 100 will now be explained in detail with reference to Figures 1-3b. The method 100 includes two major steps, including conditioning the surface 204, 212 of the first portion 202 and closing the capsule. At block 102, the method 100 includes positioning the first portion 202 of the capsule to engage the surface 204, 212 of the first portion 202 with a dosing head 302, 502 of a sealant dispenser. The first portion 202 may include an ingredient therein. In one example, the ingredient may include, but is not limited to, a pharmaceutical material, a nutritional supplement, and a nutraceutical material. In an instance, the first portion 202 may be positioned and held in place by a shuttle to be engaged with a surface of the dosing head 302. In one embodiment, the surface 204, 212 of the first portion 202 may include either the internal surface 204 of the first portion 202, or the external surface 212 of the first portion 202.

[0059] In one embodiment, a geometrical profile of the dosing head 302 of the sealant dispenser may depend on a shape of the first portion 202, and a desired position of the sealant on the surface 204, 212 of the first portion 202. In a scenario, where the surface 204, 212 of the first portion 202 is the internal surface 204 of the first portion 202 (as depicted in Figure 2a), the dosing head 302 may have a closed cylindrical geometry, such that a closed cylindrical tip of the dosing head 302 may be inserted into the first portion 202 having a hollow cylindrical portion, through an upper end of the hollow cylindrical portion. A lower end of the hollow cylindrical portion may be closed by a hemispherical portion formed below the hollow cylindrical portion.

[0060] In one embodiment, the first portion 202 may include a body of the capsule, on which the sealant may be dosed, as depicted in Figures 2a-3b, and Figures 5a-5d (explained later). In such a scenario, the second portion 416 will be a cap of the capsule, which is telescoped onto the first portion 202 after conditioning of the first portion 202 with the sealant. In another embodiment, the first portion 202 may be the cap of the capsule, on which the sealant may be dosed, as depicted in Figures 4a and 4b. Specifically, Figure 4a illustrates dosing process of the sealant onto an inner surface of the first portion 202, such that the first portion 202 is the cap of the capsule, and Figure 4b illustrates a conditioned inner surface 204-A of the first portion 202, such that the first portion 202 is the cap of the capsule. In such a scenario, the second portion will be the body of the capsule, on which the conditioned first portion 202 (cap) may be telescoped after conditioning of the first portion 202 with the sealant.

[0061] In a scenario where the surface 204, 212 of the first portion is the external surface 212 of the first portion 202 (as depicted in Figure 3a), the dosing head 502 may have the hollow cylindrical geometry, the upper end of the hollow cylindrical portion of the first portion may be inserted into a hollow cylindrical tip of the dosing head 502, such that the external surface 212 of the first portion 202 is engaged with an internal surface of the hollow cylindrical geometry of the dosing head 502.

[0062] Referring again to Figure 1, at block 104, the method 100 includes circumferentially applying a predetermined amount of the sealant onto the surface 204, 212 by the dosing head 302, 502. In one embodiment, the sealant comprises a solvent prepared by mixing water in a range of 5% to 30% by volume, with ethanol in a range of 70% to 95% by volume. Ultimately, the water content dictates the metrics of the sealant, as the water delivers the key bonding effect and ethanol is seen as a carrier agent. Should the water content be higher than desired, the capsule configuration may have a higher chance of deformation and breakage. Further, the time taken for stabilization of the excessive moisture may be longer and the capsule may have a higher degree of potential for failure. Water further provides greater volume to assist in micro-dosing of the sealant and is easily evaporated post-application.

[0063] Should the water content be too low, the likelihood of an inadequate bonding action may likely result in leakage and product failure. The amount of sealant being applied onto the surface 204, 212 of the first portion 202 should neither be more than nor less than the predetermined amount, as excessive sealant may not be able to be removed from the first portion 202. Further, an inadequate amount of sealant may not be able to make a bond at all or may make a weak bond. In one example, the predetermined amount of sealant may depend on whether conditioning is being done with the use of a vacuum or not. In one embodiment, the predetermined amount of the sealant may be in the range of 0.19 µl to 0.81 µl per millimeter diameter of the first portion 202.

[0064] In one embodiment, the sealant is adapted to be drawn into a space between the surface 204, 212 of the first portion 202 and the surface of the dosing head 302, 502 through a capillary action. Due to the capillary action, the sealant may be applied onto the surface 204, 212 by being drawn into the space, with a predetermined dosing height. In one embodiment, the predetermined dosing length may range from 2 mm to 5 mm. The predetermined dosing length may be taken along a longitudinal axis A-A’ (as shown in Figure 2a) of the first portion 202. The dosing head 302 is adapted to dwell in an area of the sealant dosed onto the first portion 202 for a predetermined dwell time ranging between 2 seconds to 5 seconds.

[0065] Once the first portion 202 is conditioned, most of the sealant is retained in the first portion 202, making the first portion 202 adhesive and pliable. In one embodiment, the sealant is adapted to be absorbed into the first portion 202 for a predetermined absorption time ranging between 2 seconds and 5 seconds. As used herein, the “predetermined absorption time” refers to the amount of time the sealant takes to be optimally absorbed into the first portion 202. If the sealant is left for a shorter predetermined absorption time on the first portion 202, the conditioning of the first portion 202 will not happen properly. Such under-conditioning of the capsule shall lead to inadequate bonding between the first portion 202 and the second portion 416, 408, 402 due to inadequate surface preparation.

[0066] In one embodiment, the dosing head 302, 502 is adapted to dwell in an area of the sealant dosed onto the first portion 202 for a predetermined dwell time. As used herein, the term “predetermined dwell time” refers to a time for which the dosing head 302, 502 remains engaged with the first portion 202 while conditioning of the first portion 202 is in progress. The dosing head 302, 502 is lifted only after the completion of the predetermined dwell time giving the sealant the opportunity to be mostly absorbed into the surface 204, 212 of the first portion 202 thereby avoiding the mechanical scraping to a sealant layer 304, 504 dosed onto the first portion 202, while lifting the dosing head 302, 502 up.

[0067] By retaining the dosing head 302, 502 in the dosing position, until the conditioning of the first portion 202 completes, the dosing head 302, 502 limits dripping of the sealant downwards due to gravity. This ensures that the sealant remains in an intended conditioned surface 304-A, 306-A on the surface 204, 212 of the first portion 202. Further, retaining the dosing head 302, 502 in the dosing position until the conditioning process completes, helps in avoiding either mechanical or vacuum-induced scraping of the sealant while pulling the dosing head 302, 502 upwards.

[0068] In cases where insufficient time has been provided for the adequate conditioning and partial absorption of the solvent into the first portion 202 an amount of excessive residue liquid will remain on the first portion 202. Commercial assembly of various capsule portions involve extremely small dimensional tolerances with close and often interference fitment, all likely to give rise to a mechanical scraping action that disrupt internally applied sealants.
The excessive residue may be scraped, shoveled, or vented as a result of the telescoping of the second portion 416 over or inside the first portion 202. Adequate capsule conditioning ensures that limited excessive residual liquid remains that could be displaced equally, so that sufficient conditioning takes place to ensure a reliable seal. Further scraping can not only displace the sealant thereby compromising the seal, but it can also result in high quantities of sealant being located and concentrated areas on the first portion 202, commonly referred to as “snowplowing”. Typically, snowplowing refers to the accumulation of the excessive moisture residue in a localized area, giving rise to over-hydration of the localized area, resulting in collapse of the capsule.

[0069] The conditioning of the first portion 202 through the partial absorption of the sealant into the first portion 202, ensures that the process of adhesion takes place prior to the enclosure of the second portion 416. This also reduces excessive residue liquid, thereby avoiding displacement of the sealant and the creation of channels due to the venting of pressure created due to telescoping engagement of the second portion 416.

[0070] In cases of over conditioning where the sealant has been exposed to the capsule portions for a longer period than desired. This results in overhydration of the sidewall, this can result in the swelling of the sidewall which limits the removal of the dosing head 302, 502 and/or the telescoping of the second portion 416.

[0071] Further over conditioning due to excessively long dwell times results in over absorption of sealant on the first portion 202, migration of the moisture through the first portion,202 and dispersing the moisture away from the intended sealing area. All of which give rise to failure in the capsule integrity due to overhydration or failure of the seal due to inadequate transferal of surface moisture to the second portion 416. In some cases, over conditioning may result in the premature drying of the conditioned surface 304-A, 306-A compromising its ability to bond to the second portion 416.

[0072] On application and absorption of the sealant, the first portion 202 undergoes conditioning, which is known as conditioning of the first portion 202. The time for which the first portion 202 is to be conditioned is one of the key aspects to be considered. If not maintained, an alteration in the character of the capsule may be noticeable throughout the conditioning stage. The longer the sealant is left on the first portion 202, the tackier and greater the propensity to bond. If the sealant is left for too long, the capsule may become overly flexible and begin to lose integrity. Loss of integrity may result in damage to the capsule due to the forces generated during recapping of the second portion 416or insertion of a membrane into the first portion 202. Further, if the sealant is left for too long, evaporation of the sealant and the capsule material may take place, resulting in dehydration and reversal of the conditioning process.

[0073] In addition, an over-conditioned capsule may encourage snow ploughing of the capsule material. As recapping takes place after insertion of a membrane, the sealant may spread and result in failure to form a continuous seal between the first portion 202 and the second portion 416. The spreading of the sealant may further stress the capsule, thereby increasing the likelihood of the capsule becoming prone to leakage.

[0074] At block 106, the method 100 includes closing the capsule after the conditioning of the first portion 202. The second portion 416 is positioned telescopically onto the first portion 202. In one example, the second portion 416 may have a similar geometrical profile as that of the first portion 202. A surface of the second portion 416 is concentrically positioned onto the surface 204, 212 of the first portion 202 conditioned with the sealant. In one embodiment, the surface of the second portion 416 may include either an internal surface (not shown) of the second portion 416, or the external surface (not shown) of the second portion 416.

[0075] In a scenario where the surface of the second portion 416 is the external surface of the second portion 416, the sealant will be applied to an internal surface 204 of the first portion 202. In this case, the second portion 416 will be inserted into the first portion 202 such that the external surface of the second portion 416 faces the internal surface 204 of the first portion 202. On the other hand, in a scenario where the surface of the second portion 416 is the internal surface of the second portion 416, the sealant will be applied at the external surface 212 of the first portion 202. In this case, the second portion 416 will be capped onto the first portion 202 such that the internal surface of the second portion 416 overlaps the external surface 212 of the first portion 202.

[0076] In one embodiment, application of the sealant hydrates the first portion 202 sufficiently, such that the first portion 202 undergoes weakening of bonds, to change a state of the first portion 202 from solid and dry to tacky, adhesive, and equally susceptible to deformation, thereby conditioning the first portion 202. The second portion 416 is brought in contact with the first portion 202 thereafter, which creates an area of fusion between the first portion 202 and the second portion 416, thereby sealing the first portion 202 and the second portion 416 together. However, the amount of sealant being dispensed from the dosing head 302, 502 is required to be maintained, as the residual moisture, if present in high amounts, may compromise integrity between the first portion 202 and the second portion 416. After the bonding of the first portion 202 and the second portion 416, the residual moisture from the sealant migrates through walls of the capsule, drying and hardening until the sealant-rich homologated zone returns to a dry and fused state.

[0077] The process of applying the sealant in effect delivers a reservoir of moisture that is transferred to the surface 204, 212 of the first portion 202, thereby treating the surface. As the sealant dose remains in place, the conditioned surface 304-A, 306-A becomes the reservoir of moisture. With the introduction of non-conditioned surface of the second portion 416 with the treated surface of the first portion 202, the reservoir transfers a portion of the moisture into the non-conditioned surface of the second portion 416, thereby hydrating the surface of the second portion 416. This further ensures that no single portion receives a higher quantity of the sealant, and this results in a more predictable and even level of absorption as well as a capsule configuration that has not overhydrated and is robust. The second portion 416 must be fused with the first portion 202 rapidly after conditioning the first portion 202 to avoid migration or dissipation of the sealant away from the sealed area, and to avoid formation of droplets of the sealant.

[0078] The sealant is discharged from the dosing head 302, 502 until the sealant covers a predetermined dosing height across the entire circumferential surface of the first portion 202 . The bonding of the first portion 202 and the second portion 416 happens efficiently as a result of optimal hydration. However, if the surface 204, 212 of the first portion 202 is over-hydrated, the capsule may lose integrity due to a weak bond. The dosing area remains isolated from the external environment and has a limited exposed area for evaporation and drying of the sealant. Further, the sealant is applied onto the surface 204, 212 of the first portion 202 with a predetermined dosing coverage ranging from 0.012 µL per mm2 to 0.13 µL per mm2.

[0079] The predetermined dosing height of the seal between the first portion 202 and the second portion 416 that are in contact with one another, is a crucial factor, which helps in managing an extent of area on which the seal may be formed. The area extent of the seal must be sufficient to provide strength to the seal, such that the first portion 202 and the second portion 416 not only stay in place but are also able to deal with any potential pressure generated and retained in enclosed volume inside the capsule. The pressure may increase in cases where the ingredients are exposed to heat, and therefore the length of the seal must be greater to provide enough strength to the seal. The pressure may be decreased due to high altitudes in a scenario where the capsules may be transported via air. In such a scenario, the length of the seal must be sufficient to make the capsule strong enough to sustain varying pressure levels.

[0080] In one embodiment, the capsule may have more than one ingredient chamber, as depicted in Figures 5a-5d. Specifically, Figure 5a illustrates a schematic diagram 600 depicting the process of dosing on an external surface of the compartment 402 of the capsule having the two compartments 402, 408, such that the compartment 402 is the first portion 202 of the capsule. Specifically, Figure 5b illustrates a schematic diagram depicting the sealant a conditioned external surface of the compartment 402 of the capsule having the two compartments 402, 408, such that the compartment 402 is the first portion 202 of the capsule . Specifically, Figure 5c illustrates a schematic diagram depicting the sealant between an internal surface of the compartment 402 and an external surface of a membrane 414 of the capsule having the two compartments 402, 408. Specifically, Figure 5d illustrates a schematic diagram depicting a combination of conditioned external surface of the compartment 402 and a conditioned external surface of the membrane 414 of the capsule having the two compartments 402, 408. In such a scenario, the capsule may include a membrane 414 that is telescopically fixed into the compartment 402 by interference fit, and bonded with the compartment 402 with help of the sealant, by using the method 100. The membrane may be adapted to divide the capsule in more than one compartments 402, 408.

[0081] In one embodiment, the membrane 414 may be considered as the first portion 202 (as explained in the paragraphs [0050] and [0060]). In such a scenario, the sealant may be dosed onto an external surface of the membrane 414, and the membrane 414 may then be telescopically fit into the compartment 402 after conditioning of the external surface of the membrane 414.

[0082] In another embodiment, the compartment 402 may be considered as the first portion 202 (as explained in the paragraphs [0050] and [0060]). In such a scenario, the sealant may be dosed onto an internal surface of the compartment 402. The inner surface of the compartment 402 gets conditioned with the help of the sealant. Consequently, the membrane 414 may be telescopically fit into the compartment 402 after conditioning of the inner surface of the compartment 402.

[0083] The second portion 416 may then be engaged with the compartment 402 with the method 100 as already explained above with reference to Figures 1-3b. The membrane 414 helps in dividing the capsule into two compartments 402, 408, for containing two different ingredients for being consumed together. In one embodiment, the method 100 may be applicable to capsules having more than two compartments. In one embodiment, the method 100 may be applicable to capsules having variable configurations.

[0084] All of the mechanical and material principles and benefits of the method 100 disclosed herein help in securing a reliable seal between compartments 402 and 408 thereby ensuring that all ingredients delivered in compartments 402 and 408 remain hermetically confined.

[0085] The method 100 ensures a continuous and efficient seal between the compartment 402 and the second portion 416, which may be capable of restricting oxygen ingress into the capsule, thereby preventing oxidation of the ingredients therein. The same helps in ensuring an efficient delivery of the dosage form as well as dosage amount, by ensuring that no part of the ingredients is accidentally oxidized. The seal further limits the degradation of moisture-sensitive ingredients such as probiotics, which in turn also have a major impact on the efficacy of such sensitive ingredients.

[0086] The method 100 helps in controlling the amount of sealant being applied to the compartment 402, thereby ensuring an optimal conditioning level of the compartment 402. Further, the method 100 also helps in controlling the predetermined absorption time of the sealant into the compartment 402, before closing the capsule with the second portion 416. Controlling the amount of the sealant being applied and the predetermined absorption time and the dwell time for which the sealant is left on the surface 404, 412, helps in achieving a seal that is robust, and long-lasting. Once the compartment 402 and the second portion 416 are sealed together, a closed environment is formed inside the capsule, and the introduced sealant is no longer exposed to the external environment nor capable of being evaporated. All the moisture is essentially “locked in” and helps in impacting the integrity of the entire capsule. The space between the compartment 402 and the second portion 416 is extremely small, which leaves a negligible margin for the introduction of surplus sealant.

[0087] While specific language has been used to describe the present disclosure, any limitations arising on account thereto, are not intended. As would be apparent to a person in the art, various working modifications may be made to the method in order to implement the inventive concept as taught herein. The drawings and the foregoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment.
, Claims:1. A method for conditioning a surface of a first portion of a capsule, the method comprising:
circumferentially applying a predetermined amount of a sealant onto the surface of the first portion of the capsule; and
retaining the sealant on the surface of the first portion for a predetermined dwell time ranging between 2 seconds to 5 seconds.

2. The method as claimed in claim 1, wherein circumferentially applying the predetermined amount of the sealant comprises positioning the first portion of the capsule to engage the surface of the first portion with a surface of a dosing head of a sealant dispenser.

3. The method as claimed in claim 2, wherein retaining the sealant comprises:
drawing of the sealant into a space between the surface of the first portion and the surface of the dosing head,
wherein the dosing head is adapted to dwell in an area of the sealant dosed onto the first portion for the predetermined dwell time ranging between 2 seconds to 5 seconds.

4. The method as claimed in claim 1, wherein a geometrical profile of the dosing head of the sealant dispenser depends on:
a shape of the first portion, and
a desired position of the sealant on the surface of the first portion.

5. The method as claimed in claim 1, wherein the predetermined amount of the sealant is in the range of 0.19 µl to 0.81 µl per millimetre diameter of the first portion.

6. The method as claimed in claim 1, wherein the sealant is applied onto the surface of the first portion with a predetermined dosing length ranging from 2 mm to 5 mm.

7. The method as claimed in claim 1, wherein the sealant is applied onto the surface of the first portion with a predetermined dosing coverage ranging from 0.012 µL per mm2 to 0.13 µL per mm2.

8. The method as claimed in claim 1, wherein the sealant comprises a solvent prepared by mixing water in a range of 5% to 30% by volume, with ethanol in a range of 95% to 70% by volume.

9. The method as claimed in claim 1, wherein on application of the sealant, the first portion undergoes the conditioning.

10. The method as claimed in claim 9, comprising closing the capsule after the conditioning of the first portion, by positioning a second portion, telescopically with the first portion , wherein:
a surface of the second portion is concentrically positioned onto the surface of the first portion conditioned with the sealant, and
the surface of the second portion fuses with the surface of the first portion due to the conditioning of the first portion and absorption of the sealant into the second portion.

11. The method as claimed in claim 10, wherein:
the surface of the first portion includes one of an internal surface of the first portion and an external surface of the first portion ; and
the surface of the second portion includes one of an internal surface of the second portion, and an external surface of the second portion.