Description:FIELD OF THE INVENTION
The present invention relates to a tabsule dosage form wherein the tablet core or caplet has a step for ensuring the pre-defined dissolution of an active ingredient. The present invention also relates to the process of preparing the tabsule dosage form with a step incorporated on the tablet core or caplet.
BACKGROUND OF THE INVENTION
Tabsules are nothing but capsule shaped tablets which are relatively bulgy as compared to the tablet and encompasses a shell coating wherein shell shows no overlapping but its distal ends interfere.
Since past many years, capsules have been recognized as a preferred dosage form for the oral delivery of active ingredients, which may be in the form of powder, liquid or granules of different compositions, for delivery to the gastro-intestinal tract of a human. The term capsule is derived from the Latin word “capsula”, meaning “a small container”. Advantages of capsules as a dosage form include the different types of shapes, colours, dosing uniformity, better taste masking, easy swallowability and their considerable dissolution.
The capsule shell is an egg-shaped hollow shell. The capsule shell has ease of swallowability, excellent taste masking, good bioavailability, and can be dissolved rapidly, reliably and safely. One type of commonly used capsule is a two-piece hard shell capsule, typically made from edible medicinal gelatin, starch, or cellulose derivatives through fine treatment and auxiliary materials and is used for containing solid powder and particles. In most cases, capsule shell manufacturing starts with the preparation of gelatin mucilage made from collagen. The preparation process involves dipping wherein stainless steel made moulding pins are dipped into gelatin for some time and with certain depth. The dipping process is then followed by drying wherein gelatin gets distributed evenly all over the body and cap and also achieves desired moisture content. The capsule body and shell are then stripped off and cut to desirable length and joined together into a pre-lock position before they get collected into containers for further processing. By and large similar process is followed for manufacturing capsules of alternate polymers also.
Being a preferable route administration due to its shape and surface characteristics, gelatin capsules have been used by many patients since ages.
The existing capsules are generally used by combining a capsule cap and a capsule body wherein longer body has an outside diameter, and a relatively shorter cap has an inside diameter that will just fit over the outside diameter of the body. Capsule cap and body being two independent parts, cap fits snugly over the body, creating an overlapping portion of the capsule and a gap is inevitably formed between capsule body and capsule cap.
However, capsule shell production also suffers from the defects such as short or long body/cap; damaged edge, rough cut, unaligned body and cap etc.
Since the tabsules come into the picture, many people have attempted the various ways to facilitate the disintegration. Out of those, one of the attempt is keeping the gap in dome area so that disintegration fastens once the patient consumes the dosage. Such gap can be of any size, precisely 1 mm or 2 mm.
United States Patent Publication No. 4,591,500 discloses tablet having the shape of a capsule, as well as a process and a device to carry out preparation of such tablets. The tablets prepared as per the said invention are easily swallowed and immediately release the granules once it arrives in the stomach or in the intestine when it is prepared with gastroresistant excipients. The device disclosed for producing capsule shaped tablet is characterized by a mould comprising at least a vertical chamber, in which the blend of suitable excipient and granules of active substance is introduced and compressed between an upper die and a lower die, each of them having the end or head acting on the blend in the form of an ogive matching the form of the corresponding head of the tablet in the shape of a capsule to be obtained, so that the division point of the tablet in two halves is represented by the step representing the connection point of the two semicapsules, and the quantity of active substance in each tablet half will be the same. A disadvantage that appeared in the disclosed tablet prepared with the claimed apparatus is that the ledge or land area must be at the center of each tablet. And thus the critical point to handle in this invention is to compress the raw materials at the same point in the die to produce each tablet.
International Publication No. WO 97/17049 discloses telescope-type capsule consisting of a cap and a body, said cap having four to six elongated, flat protrusions on its inner wall with a depth of from 30 to 100 ?m, and a length of 1.5 to 3 mm, and a narrowing positioned between the closed end and cylindrically shaped part of the capsule. The body also comprises a locking ring, the counter locking ring, which matches the locking ring of the cap and at its open end the body is provided with an area of reduced diameter formed by a circular shaped ring and a wider ring of symmetrical or asymmetrical cross-sectional profile to fit the elongated protrusions. Though the invention claims to provide a container of optimized design which guarantees increased protection against reopening and bursting, there exists the disadvantage of capsule shell with certain leakage.
United States Patent Publication No. 4,820,524 relates to the capsule-like medicament and method for producing the medicaments and apparatus thereof. The method provides a procedure for coating the caplets with gelatinous coatings to produce a shiny, capsule-like medicament wherein the method comprises individually dipping and drying first one end of each caplet into a first bath of gelatinous coating of one colour, and then the other end of each caplet into a second bath of gelatinous coating of a different colour. Though this prior art teaches the process sequences that supplement and partially replace the known standard empty gelatin capsule techniques and parameters, the disadvantage that lies with this prior art is repeated dipping and drying processes.
United States Patent Publication No. 5,213,738 relates to method for making a multi-characteristic, bi-layer, capsule-shaped tablet. The process as disclosed in this art comprises filling a die with a blend of one or more excipients and one or more active substances, including a first distinguishing ingredient, e.g., a first coloring agent, followed by leveling the first blend and cleaning the die walls the first blend and then adding a second blend including a second distinguishing ingredient, e.g., a second coloring agent, and compressing both blends longitudinally in the die into the shape of a two component capsule. Furthermore, the medicament of this art further comprises the clear coating which provides the appearance of gelatinous capsule. The disclosed prior art represents approach to provide a capsule-shaped product in the form of an elongated tablet having a coating, which provides the appearance and, therefore, the consumer acceptability of the previously popular capsule.
International Patent Publication No. WO 2020/212829 relates to multi-component pharmaceutical single dosage forms. The said dosage form comprises plurality of sub-units having capsule shaped or cup shaped body piece filled with an active drug substance and cap piece compressed in pre-determined dimensions with suitable punches to provide the multi component dosage. However, the preparation process for the said dosage requires closes attention and considerable force.
United States Patent Publication No. 9,101,546 discloses the capsule dosage forms which define the fluid flow passages between the ridges. This can be achieved with capsule that includes two capsule portions of equal sizes, dimensions and with specific moisture content. The invention also includes plurality of ridges projecting inwardly from the inner circumference of the respective capsule portion and extending along the inner circumference of the respective capsule portions in radially spaced apart relationship with one another. This design involves the interference fit but not the overlapping fir between the capsule portions.
Furthermore, process for the capsule manufacturing is general process wherein capsule body and capsule cap after manufacturing are stripped off the pins and are cut to particular length; followed by joining them together into a pre-lock position and then ejected into containers for further processing. However, this general process deals with various defects such as un-even length of body and/or cap, rough cuts etc. It is also important to precisely trim the capsule body and cap to have minimal tolerance however based on the technology that exists as of now, people are not succeeded to cut the shells below ±0.25 mm tolerance.
Also, the fill weighs of the any capsule dosage form is another challenge of the capsule manufacturing process. It is important to accurately calculate the fill weight and prepare the capsule dosage. In case of tabsule dosage form, monitoring the high fill weights is a challenge because maintaining the precise weight control in the compacted manner is not an easy task to achieve.
Furthermore, in case of overlapped capsule, maintaining the exact gap between capsule body and capsule cap is important to ensure the pre-defined dissolution profile. Unaligned body and cap due to excessive gap may cause defect such as telescoped. With this defect, the dissolution and its release profile of the active may get affected after consuming the drug product.
Furthermore, shells are manufactured by capsule manufacturers and based on the known technologies, the shells cannot be manufactured for precise cut lengths. The best tolerances manage as of date is ±0.40 mm. This leads to variation in the gap maintained between two shells on both sides of caplets. At times these variation leads to oversize gap or undersize gap. Such products needs inspection and segregation process. This not only incurs additional cost, also adds one more processing step leading to time loss and process loss of finished product.
The caplets is an another dosage form wherein oblong shaped tablets are prepared and are now available in market but the patient acceptance has not yet reached for such kind of dosage forms. Thus, there exists the need to combine the consumer acceptance of a capsule shaped with a tablet.
None of the prior reference have overcome the problems such as unaccepted tolerance limit, inaccurate cut length or gap, précised fill weight while preparing the tabsule dosage form with the defined dissolution of the active ingredient contained therein.
Also, it is sometime difficult to prepare tabsule dosage form with specific gap length as per the client’s requirements. Such difficulties may arise due to the possible cut length and semi tolerance attached to that. Thus, there exists a need to ensure the precise gap to enable the defined dissolution profile.
Moreover, many innovators, in the past, have attempted to formulate the medicaments with pre-defined gap between two polymer shells. However, in case of any further variation in such pre-defined gap occurs, that may lead to disturb the dose release as required.
Thus, the present invention describes the modified tabsule dosage form to achieve the pre-defined dissolution wherein the modified tabsule dosage form comprises the step generated over the tablet core or caplet followed by layering of polymer shell.

SUMMARY OF THE INVENTION
A pharmaceutical dosage form, preferably capsule shaped tablet, also known as tabsule dosage form. A disclosed tabsule dosage form comprises tablet core or caplet formulated with a step generated over the tablet core or caplet; followed by overlapping a pre-cut shell on it. The step on tablet core/caplet is formulated by precisely manufacturing either upper and/ or lower punch and/ or a die during manufacturing with micron tolerance of 20 to 30 microns. The steps over the tablet core or caplet are formulated to maintain the pre-defined gap between two polymer covers in the finished product for ensuring dissolution of active substances and also ensuring the regulatory declarations made.
The invention further discloses the process to prepare the tabsule dosage form. Other and more detailed objects of this invention will be apparent from the following description drawings and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1: Represents the normal tablet core or caplet without the step (Prior art core)
Figure 2: Represents the tablet core with step on upper or lower face prepared by altering/ changing the design of upper or lower punch.
Figure 3: Represents the tablet core with step on upper and lower face prepared by altering/ changing the design of upper and lower punch.
Figure 4: Represents the tablet core with step on sideways of core prepared by altering/ changing the design of Die.
DETAILED DESCRIPTION OF THE INVENTION
The term "tablet core", as used in the present invention, can interchangeably be used with the terms such as “core”, “placebo”, “placebo core tablet”, “tablet core composition”, “core composition”, “caplets” etc.
The term “tabsule” as used throughout the specification means the capsule shaped tablet having tablet core or caplet; followed by polymer layering.
The term “step” as used throughout the specification means the protrusion made on the tablet core or caplet of specific length, width and thickness. The step can be made on upper face and/or lower face and/or all over the core body depending upon the dissolution profile requirements.
The term “polymer” as used throughout the specification can be selected from the group consisting of ethyl cellulose, cellulose acetate, Eudragit S, Eudragit L, cellulose acetate phthalate (CAP), hydroxypropyl methyl cellulose, hydroxypropyl methylcellulose acetate succinate (HPMCAS), hydroxypropyl methyl cellulose phthalate (HPMCP), Opadry, pullulan, or any combination thereof.
The term “polymer shell” as used throughout the specification is premanufactured polymer shell with inside diameter, adequate wall thickness and predefined cut length as desired by the inventors. Such premanufactured polymer shell comes with two halves wherein each half has one open end and other closed end with preferably hemi-spherical shape.
The above said “polymer shell” can be selected from the group consisting of gelatin, ethyl cellulose, cellulose acetate, Eudragit S, Eudragit L, cellulose acetate phthalate (CAP), hydroxypropyl methyl cellulose, hydroxypropyl methylcellulose acetate succinate (HPMCAS), hydroxypropyl methyl cellulose phthalate (HPMCP), Opadry, pullulan, Hydroxy prototyped starches, modified starches, Native starches or any combination thereof.
The term “width” which is used while referring in the step shall mean along the length side of the tablet core or caplet. This step can be continuous or in segment along any face of the tablet core.
In one aspect of the invention the step generated over the tablet core or caplet helps in facilitating the dissolution of the active ingredient contained therein and helps to diminish the need of precisely maintaining the gap between two shells while encapsulation.
In another aspect of the invention, the step generated over the tablet core or caplet ensures the pre-defined gap between two polymer shells and to enable the pre-defined dissolution of the active ingredient contained therein.
In one embodiment, the invention provides a new design of the tabsule which involves modification in the tablet core or caplet itself by precisely manufacturing either upper punch and/ or lower punch and/ or a die during manufacturing with micron tolerance of 20 to 30 microns.
In another embodiment the invention provides a new design of the tablet core that involves the step generated over the tablet core or caplet itself.
In one embodiment, the step generated over tablet core or caplet is made by changing the punches and/or die design. In one embodiment, one can change all three designs i.e., upper punch, lower punch and die or change in any two or any one of them can be combined, based on the knowledge and the requirements of the manufacturer.
In another embodiment, a tabsule dosage form comprises tablet core or caplet formulated with a step generated over the tablet core or caplet; followed by layering a pre-cut tablet core or caplet with polymer shell.
In another embodiment, the thickness of the proposed step generated over the tablet core or caplet ranges from about 05 µ to about 1000 µ with the desired width of which the gap is required or specified between two polymer shells. Specifically, the thickness of the step ranges from about 10 µ to about 350 µ and more specifically it ranges from about 25 µ to about 200 µ.
In another embodiment, the width of the step ranges from about 0.05 mm to about 10.0 mm. This will be mainly derived by the formulator based on his studies and desired dissolution release profile outcome.
In one embodiment, the invention provides the process to prepare the tabsule dosage comprising:
a. Preparing the tablet core or caplet with step; and
b. layering the tablet core or caplet with polymer shell.
In another embodiment, the invention provides the process to prepare tablet core or caplet comprising:
a. Manufacturing a suitable metal upper punch and/or lower punch and/or die in combination or alone, having a step feature, with the precise micron tolerance; and
b. Transferring the step on the tablet core or caplet while punching operation during manufacturing on tableting machine.
In another aspect, the invention provides the process to prepare the tabsule dosage comprising:
a. Manufacturing a suitable metal upper punch and/ or lower punch and/ or die in combination or alone having step feature with the précise micron tolerance to get the tablet shaped core of pre-defined length, width and thickness;
b. Transferring the step on the tablet core or caplet of suitable formulation while punching operation during manufacturing on the tableting machine; and
c. Layering the tablet core or caplet with polymer shell.
In one aspect, the invention provides the change in upper punch or lower punch tool by designing the upper punch or lower punch as shown in figure 2 with micron tolerance of 20 to 30 microns.
In another aspect, the invention provides the change in upper punch and lower punch tool by designing the upper punch and lower punch as shown in figure 3 with micron tolerance of 20 to 30 microns
In one embodiment, the invention provides the change in die by designing a die as shown in figure 4 with micron tolerance of 20 to 30 microns.
In one embodiment, the invention provides the change in all punches and die by combination of design shown in figure 2, 3, 4 with micron tolerance of 20 to 30 microns.
In one aspect of the invention, the invention provides the step generated over the tablet core/ caplet which keeps the dissolution profile unaffected even during any variation in the capsule shell.
As unprecise cut lengths lead to the variation in the gap maintained between two shells on both sides of caplets, resulting in oversize gap or undersize gap. Thus, in one aspect, the invention provides the advantage of having constant gap with minimum tolerance of 0.1 mm irrespective of cut length variation in capsule shell which may lead to maximum gap variation up to 0.8 mm.
In another embodiment, the invention provides the pre-defined dissolution of the active contained therein by providing the step generated over tablet core or caplet.
In one embodiment the invention provides the tabsule dosage form comprising tablet core or caplet with step and polymer shell layer wherein tabsule dosage is prepared by:
a. Manufacturing a suitable metal upper punch and/ or lower punch and/ or die in combination or alone having step feature with the précise tolerance of 20–30 micron to get the tablet shaped core of pre-defined length, width and thickness;
b. Transferring the step on the tablet core or caplet of suitable formulation while punching operation during manufacturing on the tableting machine; and;
c. Layering the tablet core or caplet with polymer shell.

In one aspect, the layered polymer shells can be glued to ensure intactness of polymer over the tablet core or caplet. The glue, as used herein, can be any pharmaceutically accepted food grade gum. The term “food-grade gum” means any food-grade material that has the properties of a gum. Examples of food-grade gums include pullulan, gum arabic, gum karaya, gum tragacanth, gum ghatti, agar-agar, guar gum, locust bean gum, konjac, alginates, carrageenan, pectin, tara gum, xanthan gum, gellan gum, pullulan, curdlan, cellulose microcrystalline cellulose (MCC), carboxymethylcellulose (CMC) gum, methylcellulose (MC), hydroxypropyl methylcellulose (HPMC), gelatin, chitosan, and combinations thereof.
In another aspect the tablet core or caplet may be coated with suitable film forming agent to avoid dusting of formulation while tabsule manufacturing process. The coating can be done by any prior known techniques. The coating polymer can be selected from any film forming agent but not limited to gelatin, CMC, sodium CMC, hydroxypropyl methyl cellulose, HPMC phthalet. HPMC acetate succinate, pullulan, poly vinyl pyrrolidines, ethyl cellulose (Ethocel 10 CUPS), EUDRAGIT derivatives or any combination thereof.
In another aspect, preparing the tabsule in accordance with the present invention, compressible powdered material is compressed in an appropriately shaped die between appropriately shaped upper and lower punches. These punches and dies are designed to form a tablet having the configuration as shown in figure 2, figure 3, figure 4 alone or combination thereof.
In another aspect, the tabsule dosage form of the invention is used as pharmaceutical, nutraceutical or food supplement formulation/ application/ intention.
In one embodiment, the pharmaceutically active ingredient(s) that may be contained in the tabsule of the present invention can be any of a large variety of materials. By way of example of active pharmaceutical ingredients that may be incorporated in the present tabsule, there may be mentioned analgesics, decongestants, antihistamines, antitussives, antacids, gastric protestants, appetite suppressants, bronchodilators, sleep aids, sleep suppressors, vitamins, laxatives, antibiotics, antispasmodic, etc. and mixtures thereof.
In another aspect, in addition to the pharmaceutically active ingredients described above, the tablets of the present invention may also contain other conventional solid formulation additives and aids. These include ingredients such as delivery agent, absorption enhancer, vehicle, filler (also known as diluents), binder, lubricant, glidant, disintegrant, crystallization retarders, acidifying agent, alkalizing agent, preservative, antioxidant, buffering agent, chelating agent, complexing agents, surfactant agent, emulsifying and/or solubilizing agents, sweetening agents, wetting agents stabilizing agent, colouring agent, flavouring agent, and/or to improve administration, and/or absorption of the active substance. A person skilled in the art may select one or more of the aforementioned excipients with respect to the particular desired properties of the solid oral dosage form by routine experimentation and without any undue burden. The amount of each excipient used may vary within ranges conventional in the art. Techniques and excipients which may be used to formulate oral dosage forms are described in variety of books/ journals such as Handbook of Pharmaceutical Excipients, 6th edition, Rowe et al., Eds., American Pharmaceuticals Association and the Pharmaceutical Press, publications department of the Royal Pharmaceutical Society of Great Britain (2009); and Remington: the Science and Practice of Pharmacy, 21th edition, Gennaro, Ed., Lippincott Williams & Wilkins (2005).
In another embodiment, the invention further discloses the compression step to prepare the tablet core or caplet wherein the compression step involves changes in upper punch and/ or lower punch and/ or die design with micron tolerance of 20-30 microns. Such changes in any one of them or two of them or changes in all of them i.e., upper punch, lower punch and die, generates the step over the tablet core or caplet.
In one embodiment, the invention further discloses the layering of tablet core/ caplet with a film forming polymeric substance which will simulate the appearance and function of tabsule dosage form. A number of film forming materials are known in this art which will serve this purpose. By way of example, the following may be mentioned hydroxypropyl methyl cellulose, HPMC phthalet. HPMC acetate succinate, pullulan, HPMC along with alternate gelling systems, ethyl cellulose (Ethocel 10 CUPS), EUDRAGIT derivatives, modified or native starches etc. The thickness of the layering of film forming polymer that is applied to the tablet core or caplet of this invention may vary. The only essential limit is that it be able to simulate the appearance and function of tabsule dosage form.
The following examples serve to illustrate the embodiments of the present invention. However, they do not intend to limit the scope of the invention. It is obvious to those skilled in the art to find out the composition for other dosage forms and substitute the equivalent excipients as described in this specification or with the one known to the industry.
Examples:
The following examples further illustrate the invention and do not limit the scope of the invention. By referring these examples, the scope and the advantages of the invention can be better understood.
A. Preparation of prior-art punches and dies.
Punches were prepared with prior art design to get the caplet/ tablet core with the dimensions as given below.
Length of caplet = 19.15 mm
Width of caplet = 6.12 mm
Diameter / thickness of caplet = 6.15 mm

B. Preparation of Modified Punches and Dies
i. Preparation of Modified Upper Punch
The upper punch was produced to have a step in the centre of punch wherein step was 2.2 mm in width and 0.15 mm in thickness. Thus, the overall dimensions of tablet core or caplet was as follows:
Length of caplet = 19.15 mm
Width of caplet = 6.12 mm
Diameter / thickness of caplet in centre = 6.30 mm

ii. Preparation of Modified Lower Punch
The lower punch was produced to have a step in the centre of punch wherein step was 2.2 mm in width and 0.15 mm in thickness. Thus, the overall dimensions of tablet core or caplet was:
Length of caplet = 19.15 mm
Width of caplet = 6.12 mm
Diameter / thickness of caplet in centre = 6.30 mm

iii. Preparation of Modified Die
The die was produced to have a step in the centre of punch wherein step was 2.2 mm in width and 0.15 mm in thickness on both sides. Thus, the overall dimensions of tablet core or caplet was:
Length of caplet = 19.15 mm
Width of caplet in centre = 6.42 mm
Diameter / thickness of caplet = 6.15 mm

C. Capsule shells used – The inventors, within the scope of the inventions, have used the gelatin capsule shells manufactured by ACG Associated Capsules Pvt Ltd with following dimensions:
- Diameter of shell = 6.40 mm +/- 0.03 mm
- Length of shell = 9.40 mm +/- 0.4 mm
- Wall thickness of shell = 0.100 mm +/- 0.01 mm
- Colour of shells = Blue

D. Manufacturing of caplets/ tablet core
The tablet core or caplets were prepared by using the process as given below:
T1- 10000 caplets/ tablet core were manufactured on Protab-300 machine of ACG-Engineering P Ltd. using prior art upper punch, lower punch and die. The active ingredient used herein this formulation was Acetaminophen.
T2- 10000 caplets/ tablet core were manufactured on Protab-300 machine of ACG-Engineering P Ltd. using modified upper punch as described in (B)(i) and prior art lower punch and die. The active ingredient used herein this formulation was Acetaminophen.
T3- 10000 caplets/ tablet core were manufactured on Protab-300 machine of ACG-Engineering P Ltd. using modified lower punch as described in (B)(ii) and prior art upper punch and die. The active ingredient used herein this formulation was Acetaminophen.
T4- 10000 caplets/ tablet core were manufactured on Protab-300 machine of ACG-Engineering P Ltd. using modified Die as described in (B)(iii) and prior art upper punch and lower punch. The active ingredient used herein this formulation was Acetaminophen.
T5- 10000 caplets/ tablet core were manufactured on Protab-300 machine of ACG-Engineering P Ltd. using modified upper punch [(B)(i)], modified lower punch [(B)(ii)] and modified die [(B)(iii)]. The active ingredient used herein this formulation was Acetaminophen.

E. Encapsulation trials and evaluation criterion
All the above caplets/ tablet core were encapsulated with the shells as described in C above on ACG Engineering Pvt. Ltd tabsule machine (TABSULE-40) at 40000 nos/hr speed. The Tabsules were then collected and 100 such finished Tabsules were evaluated for open gap between the two shells with suitable vernier calliper, and 12 shells were evaluated for dissolution of shells in first 2 mins and 5 mins. The method used was USP prescribed method of 0.1N HCl solution at 37 deg C using paddle and Sinker.

F. Results
a. Evaluation of gap found in 100 shells

Trial No Average Gap in mm Range of Gap in mm
T1 2.202 mm 1.8 to 2.5 mm
T2 2.196 mm 2.1 to 2.3 mm
T3 2.203 mm 2.1 to 2.3 mm
T4 2.193 mm 2.1 to 2.3 mm
T5 2.201 mm 2.1 to 2.2 mm

b. Drug release in 2 and 5 mins at 0.1 N HCl as per USP method with paddle.
Trial no Gap Drug release in % after 2 min Drug release in % after 5 min
T1 1.9 mm 14 % 55 %
2.5 mm 28 % 72 %
T2 2.1 mm 19 % 68 %
2.3 mm 21 % 64 %
T3 2.1 mm 20 % 65 %
2.3 mm 21 % 69 %
T4 2.1 mm 19 % 64 %
2.3 mm 22 % 67 %
T5 2.1 mm 20 % 68 %
2.2 mm 21 % 67 %
** All the figures mentioned above as drug release were average of 12 shells evaluated.

As can be seen from above that the consistency in gap is much improved due to modifications done as suggested in this innovative method. Also this consistency helps to ensure drug release in narrow range.
, Claims:1. A tabsule dosage form comprising tablet core or caplet with step generated over the tablet core or caplet, followed by layering with polymer shell.
2. The tabsule dosage form as claimed in Claim 1, wherein the thickness of the step generated over tablet core or caplet ranges from about 05 µ to about 1000 µ.
3. The tabsule dosage form as claimed in Claim 1, wherein the width of the step generated over tablet core or caplet ranges from about from 0.05 mm to 10.0 mm.
4. The polymer shell as claimed in Claim 1 wherein polymer shell is a premanufactured polymer shell in a desired inside diameter, adequate wall thickness and predefined cut length.
5. The polymer shell as claimed in Claim 4, shall have one open end and other closed end with preferably hemi -spherical shape.
6. The polymers shell as claimed in Claims 1, is selected from the group consisting of gelatin, ethyl cellulose, cellulose acetate, Eudragit S, Eudragit L, cellulose acetate phthalate (CAP), hydroxypropyl methyl cellulose, hydroxypropyl methylcellulose acetate succinate (HPMCAS), hydroxypropyl methyl cellulose phthalate (HPMCP), Opadry, pullulan, Hydroxy prototyped starches, modified starches, Native starches or any combination thereof.
7. The tablet core or caplet as claimed in Claim 1, comprising
a. Manufacturing a suitable metal upper punch and/ or lower punch and/ or die in combination or alone, having step feature, with the précise micron tolerance and;
b. Transferring the step on the tablet core or caplet of suitable formulation while punching operation during manufacturing on the tableting machine.
8. The tablet core or caplet as claimed in Claim 7, optionally be coated with the suitable coating polymer.
9. The suitable coating polymer as claimed in Claim 8, can be selected from any film forming agent not limited to but such as gelatin, CMC, sodium CMC, hydroxypropyl methyl cellulose, HPMC phthalet. HPMC acetate succinate, pullulan, poly vinyl pyrrolidines, ethyl cellulose (Ethocel 10 CUPS), EUDRAGIT derivatives, Hydroxy prototyped starches, modified starches, Native starches or any combination thereof.
10. The polymer shell as claimed in Claim 1, is layered over the tablet core or caplet using the glue to ensure the intactness of polymer over the tablet core or caplet.
11. The glue as used in Claims 10, is selected from the group consisting of pullulan, gum arabic, gum karaya, gum tragacanth, gum ghatti, agar-agar, guar gum, locust bean gum, konjac, alginates, carrageenan, pectin, tara gum, xanthan gum, gellan gum, pullulan, curdlan, cellulose microcrystalline cellulose (MCC), carboxymethylcellulose (CMC) gum, methylcellulose (MC), hydroxypropyl methylcellulose (HPMC), gelatin, chitosan, and any combinations thereof.
12. The tabsule dosage form as claimed in Claim 1, ensures the pre-defined dissolution of the active ingredient while maintaining pre-defined gap, irrespective of the length variation of the two polymer shells.
13. The tabsule dosage form as claimed in Claim 1, ensures the pre-defined gap and the dissolution of the active ingredient due to the step generated over the tablet core or caplet.
14. The tabsule dosage form as claimed in Claim 1, is used in pharmaceutical, nutraceutical or food supplement formulations and applications.
15. The process to prepare tabsule dosage form comprising;
a. Manufacturing a suitable metal upper punch and/ or lower punch and/ or die in combination or alone having step feature with the précise micron tolerance to get the tablet shaped core of pre-defined length, width and thickness;
b. Transferring the step on the tablet core or caplet of suitable formulation while punching operation during manufacturing on the tableting machine, and;
c. Layering the tablet core or caplet with polymer shell.
16. The process to prepare tabsule dosage form as claimed in Claim 15, wherein manufacturing a suitable metal upper punch and/ or lower punch and/ or die in combination or alone is carried on with the précise micron tolerance of 20–30 microns for the preparation of step on the tablet shaped core or caplet.
17. The process as claimed in Claim 15, comprising tablet core or caplet with step and polymer layering, is prepared by
a. Manufacturing a suitable metal upper punch and/ or lower punch and/ or die in combination or alone having step feature with the précise tolerance of 20–30 micron to get the tablet shaped core of pre-defined length, width and thickness;
b. Transferring the step on the tablet core or caplet of suitable formulation while punching operation during manufacturing on the tableting machine, and;
c. Layering the tablet core or caplet with polymer shell.