Abstract: Abstract: The present invention relates to a single use interchangeable primary container that contains drug in the form of solution, suspension irrespective of viscous and non-viscous liquid. The present invention also relates to an interchangeable single use primary drug container comprising (i) a cartridge holder made of plastic, more specifically polyethylene; (ii) a cartridge that contains drug in the form of solution, suspension, irrespective of viscous or non-viscous liquid; and (iii) a plunger made of stainless steel to deliver the required dose and (iv) a needle with a tamper evident cap. A Cartridge-holder system that can be converted into syringe system and can be operated manually as well as electronically as per requirement, has been disclosed.
DESC:“Interchangeable primary drug container along with a needle with a tamper evident cap”
Field of Invention
The present invention relates to a single use interchangeable primary container that contains drug in the form of solution, suspension irrespective of viscous and non-viscous liquid. The present invention also relates to an interchangeable single use primary drug container comprising (i) a cartridge holder made of plastic, more specifically polyethylene; (ii) a cartridge that contains drug in the form of solution, suspension, irrespective of viscous or non-viscous liquid; and (iii) a plunger made of stainless steel to deliver the required dose and (iv) a needle with a tamper evident cap. The present invention also relates to a single use interchangeable primary container that contains a cartridge-holder combination that can be converted into a syringe system and interchangeably can be operated manually as well as electronically as per requirement and might be capable of administering all types of injectable including solution, suspension, viscous liquid and combination thereof intended for anesthetic solution for dentistry, Hyaluronic acid solution for skin care and other injectable like insulin and other pharmaceuticals administered subcutaneously or intramuscularly.
Background of the Invention
Electronic syringes are known in the art. Typical uses for such devices include injecting biocompatible material, specifically anesthetic such as block, conduction and para-apical anesthesia through bone tissue and administering insulin and other pharmaceuticals.
High pressure injection during therapeutic procedures is typically done manually. The most common approach is the use of a hand-gripped syringe which is intended to enable the user to apply sufficient force to the plunger to inject the medicaments stationed inside it. These devices are used in coronary angioplasty procedures as well as many other vascular, urological and general surgical procedures. A commercial example of such a device is the ANGIOJECT syringe which is sold by ACS.
Though both the above mentioned approaches gather certain advantages as well as disadvantages. There are several disadvantages associated with conventional manual syringes used in dentistry applications. For example due to uneven thumb pressure applied on the thumb rest, the practitioner has very little control over the flow rate of medicament exiting the needle. As a result it is virtually impossible to achieve a substantially constant flow rate with manual syringe. So user may face problem due to uncontrolled flow rate of anesthetic while using for delivering anesthetic solution.
The electronic driven syringes possess some kind of disadvantages. High pressure therapeutic drug delivery is performed manually. Electronically driven syringes are not capable of withstand high pressure thus unable to be used in delivering viscous liquid such as hyaluronic acid solutions.
Our Inventors of the present invention surprisingly find out a solution of the above mentioned problems in an economic way. The said invention comprises a simple cartridge holder system that eventually turns out to be a manually driven syringe when attached with a plunger made of stainless steel and again can be attached to an electronically driven system to act as an electronically driven syringe thus overthrowing all the drawbacks of both the systems making it a single use interchangeable primary drug delivery container.
BRIEF DESCRIPTION OF THE FIGURES
Other features of the present invention will be more readily understood from the following detailed description of exemplary embodiments thereof when read in conjunction with the accompanying drawings.
Figure 1 describes the complete device comprising (i) Cartridge holder, (ii) Cartridge containing drug product, (iii) Plunger for drug delivery and (iv). Needle with tamper evident cap.
Figure 2 illustrates the Plunger system particularly containing plunger rod and thumb rest.
Figure 3 depicts the dismantled view of plunger system. Clearly represent (i) Flange Head, (ii) Plunger rod, (iii) Thumb rest and (iv) Plunger nut.
Figure 4(a-b) depicts the schematic view of the Cartridge holder containing teeth to strengthen the anchorage between the holder and the Plunger nut.
Figure 5 describes the glass cartridge containing drug product clearly demonstrating Aluminum seal and Rubber stopper.
Summary of the Invention
One of the embodiments of the present invention describes a drug delivery container that can be interchangeably operated in manual and electronically driven mode.
Another embodiment of the present invention discusses the said container comprises of (i) a cartridge holder made of plastic, more specifically polyethylene; (ii) a cartridge that contains drug in the form of solution, suspension, irrespective of viscous or non-viscous liquid; and (iii) a plunger made of stainless steel to deliver the required dose.
One of the unique embodiments of the present invention relates to the various forms of therapeutic agents that can be administered by the present invention.
Another embodiment of present invention discloses a simple cartridge holder system that eventually turns out to be a manually driven syringe when attached with a plunger made of stainless steel and again can be attached to an electronically driven system to act as an electronically driven syringe thus overthrowing all the drawbacks of both the systems making it a single use interchangeable primary drug delivery container.
Another embodiment of present invention describes the material of construction of Cartridge holder, Cartridge and Plunger.
Another embodiment of present invention discusses the different types of needles with tamper evident cap that can be accompanied with the present invention for effective working of the invention.
It is noted that aspects of the invention described with respect to one embodiment, may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and/or incorporate any features of any other claim although not originally claimed in that manner. These and other objects and/or aspects of the present invention are explained in detail in the specification set forth below.
Detailed Description of the Invention
The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, this embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the inventionto those skilled in the art.
Like numbers refers to like elements throughout. In the figures, the thickness of certain lines, layers, components, elements or features may be exaggerated for clarity. Broken lines illustrate optional features or operations unless specified otherwise. One or more features shown and discussed with respect to one embodiment may be included in another embodiment even if not explicitly described or shown with another embodiment.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. As used herein, phrases such as "between X and Y" and "between about X and Y" should be interpreted to include X and Y. As used herein, phrases such as "between about X and Y" mean "between about X and about Y." As used herein, phrases such as "from about X to Y" mean "from about X to about Y."
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and/or clarity.
Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
It will be understood that when an element is referred to as being "on", "attached" to, "connected" to, "coupled" with, "contacting", etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, "directly on", "directly attached" to, "directly connected" to, "directly coupled" with or "directly contacting" another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.
The terms “medicament”, “therapeutic agent”, “active agent”, “drug” used interchangeably herein refer to and include, an agent, drug, compound, composition of matter, or mixture thereof, including its formulation, which provides some beneficial effect.
The term “Tamper Evident” thereof meansa device or process that makes unauthorized access to the protected object easily detected. Seals, markings or other techniques may be tamper indicating.
The term “Needle” discloses an object thatis any thin and cylindrical object which has a sharp bevel on its end. A medical needle is hollow and has a hole in the middle to allow the flow of medication into the body of a human being or animal. Medical needles consist of three parts made of stainless steel because of its high resistance to corrosion. The three parts of a needle are the shaft, which is the longest part of the needle, the bevel, which is the slanted tip of the needles, and the hub, which fits firmly onto the tip of the syringe or the vials.
When a needle penetrates into the body of a human being or animal, the bevel, which is the slanted tip of the needle, creates a narrow hole in the skin of a person to allow the fluid in the syringe to be injected into the person.
Once the needle is withdrawn from the skin of a person, the slit closes to limit the leakage of medication or blood.
For an intramuscular injection (IM), a 21 and 23 gauge needles which are 1 to 1.5 inches long are preferred or recommended for an adult while a 25 to 27 gauge needle which is 1 inch long is recommended for a child.
For a subcutaneous (SQ) injection, a 25 to 27 gauge needle which is 3/8 to 5/8 inches long is recommended for both children and adults. However, some medications for diabetes recommend the use of a 30 to 31 gauge needle which is 1/3 inch long. These types of needles are chosen because, for one reason, the subcutaneous medications are injected and deposited on the loose connective tissues which are supplied with fewer blood vessels hence low absorption rate of the medication into the blood stream of a person. Another reason is that this layer of tissue consists of many pain receptors which dictate the use of non-irritating, water-soluble medications in small doses.
Further characteristics of the invention will be made clearer by the detailed description that follows, referring to a purely exemplary and therefore non-limiting embodiment thereof, illustrated in the appended drawings, in which:
Figure 1 describes the complete device comprising (i) Cartridge holder, (ii) Cartridge containing drug product, and (iii) Plunger for drug delivery, and (iv) A needle with a temper evident cap. The said cartridge holder (Figure 4) is typically made of plastic material. Examples of useful materials include, but are not limited to polycarbonate, polyolefin such as polypropylene (PP), polyethylene (PE), or cyclic olefin (COC), polyester such as polyethylene terephthalate (PET) or polyethylene napthalate (PEN), polyamide (nylon), or other well-known materials in the plastics art. Within Polyethylene, LDPE (Low density poly ethylene) as well as HDPE (High density polyethylene) both can be used as the polymeric body. Amorphous plastics such as amorphous nylon exhibit high transparency and may also be suitable.
The drug containing cartridge is inserted within the holder. The holder has teeth to strengthen the anchorage between the holder and the Plunger nut.
The Cartridge (Figure 5) is typically made of glass more specifically USP Type I Glass. Glass containers for pharmaceutical use are intended to come into direct contact with pharmaceutical products. Glass used for pharmaceutical containers is either borosilicate (neutral) glass or soda-lime-silica glass. Borosilicate glass contains significant amounts of boric oxide, aluminum oxide, and alkali and/or alkaline earth oxides. Borosilicate glass has a high hydrolytic resistance and a high thermal shock resistance due to the chemical composition of the glass itself: it is classified as Type I glass. Soda-lime-silica glass is asilica glass containing alkaline metal oxides, mainly sodium oxide; and alkaline earth oxides, mainly calcium oxide. Soda-lime-silica glass has a moderate hydrolytic resistance due to the chemical composition of the glass itself; it is classified as Type III glass. Suitable treatment of the inner surface of Type III soda-lime-silica glass containers will raise the hydrolytic resistance from a moderate to a high level, changing the classification of the glass to Type II.
The following recommendations can be made as to the suitability of the glass type for containers for pharmaceutical products, based on the tests for hydrolytic resistance. Type Iglass containers are suitable for most products for parenteral and non-parenteral use. Type II glass containers are suitablefor most acidic and neutral aqueous products for parenteral and non-parenteral uses. Type II glass containers may beused for alkaline parenteral products where stability data demonstrate their suitability. Type III glass containers usuallyare not used for parenteral products or for powders for parenteral use, except where suitable stability test data indicate that Type III glass is satisfactory.
Again the cartridge (Figure 5) comprises of Aluminium seal for withstanding leakage from the open mouth of the cartridge and sealed with the help of Rubber so that the needle can easily penetrate. The other end of cartridge is blocked by Rubber more specifically bromo butyl rubber.
The tamper evident cap shown in Figure 1, has four projections that kept pierced inside the protective hub that have four aperture where the projections fit accurately thus forming a strong anchorage between the protective hub of the needle and the tamper evident cap. At the time of use that tamper evident cap is removed and the device becomes ready to use.
Figure 2 illustrates the Plunger system particularly containing plunger rod and thumb rest. The plunger can be made of stainless less steel, plastics, glass or combination thereof depending upon the drug material used. One of the preferred technique of present invention promotes the use of stainless steel as the material of construction of the plunger system while handling viscous products such as HA products or products containing HPMC or other polymers as inactive ingredient as these material asks for employing large force while administering that only stainless steel can withstand.
The plunger system basically comprises of a Plunger rod containing Thumb rest to apply the force and a disk shape flange that will be adjacent with the rubber stopper of the cartridge to facilitate the uniform distribution of force throughout the rubber stopper thus avoiding the problem related to uneven force distribution.
The Plunger nut (Figure 2 & 3) keeps the plunger attached with the Cartridge holder. The Sockets of the Plunger nut hold the teeth on the Cartridge holder thus ensuring a strong anchorage between them. Figure 3, 4 and 5 shows each part of the device of the present invention individually.
First of all the Cartridge is inserted within the holder. The plunger rod is attached with the cartridge holder with the help of plunger nut. The suitable needle is embedded within the rubber seal of the cartridge thus making the device ready to use.
The most surprising aspect of present invention is, it can be interchangeably operated, manually or electronically. The Cartridge along with the cartridge holder can be attached with any of the marketed electronic injector device.
According the present invention, the interchangeable primary drug container may carry various actives for administration in subcutaneous or intramuscular route selected from those of antibiotics, steroids, monoclonal antibodies, hyaluronic acid compounds or derivatives thereof and may also be useful to carry hydroxyl propyl methyl cellulose or derivatives or related compounds as inactive. The term antibiotic is not limited to antibacterials, are a type of antimicrobial used in the treatment and prevention of bacterial infection.
They may either kill or inhibit the growth of bacteria. Antibiotics may also possess antiprotozoal activity. Antibiotics are not effective against viruses such as the common cold or influenzaErythromycin, Clindamycin, Gentamycin, Tetracycline, Meclocycline, and (Sodium) sulfacetamide or combinations thereof. Most of the eye infections are treated with combination of antibiotics and steroids. Thus term antibiotic is also related to combination of steroid and antibiotics. The type of combination is chosen based on the type of eye infection all about. The combinations may be selected from dexamethasone, tobramycin, loteprednol, sulfacetamide sodium, neomycin, polymyxin B, prednisolone, bacitracin, hydrocortisone, flurometholone, gentamicin or combinations thereof.
The term ‘HA’ is not limited to Hyaluronic Acid (HA) or its derivatives or combinations thereof, HA is also known as hyaluronan or hyaluronate, is a carbohydrate, more specifically a mucopolysaccharide occurring naturally throughout the human body. It can be several thousands of sugars (carbohydrates) long. When not bound to other molecules, it binds to water giving it a stiff viscous material. This viscous Gel is one of the most heavily researched substances, the inventors of the present application have attempted to deliver the same using the device in eye surgery. Its function in the body is, amongst other things, to bind water and to lubricate movable parts of the body, such aseye muscles.
The term MAB (mono clonal antibody) is not limited to the following otherwise selected from wherein the monoclonal antibody is selected from the group consisting of abagovomab, afelimomab, anatumomabmafenatox, arcitumomab, bectumomab, besilesomab, capromab, edobacomab, edrecolomab, elsilimomab, enlimomab, enlimomabpegol, epitumomabcituxetan, ibritumomabtiuxetan, imciromab, inolimomab, mitumomab, oregovmab, satumomab, sulesomab, technetium (99mTc) nofetumomabmerpentan, tositurnomab, vepalimomab, zolimomabaritox, adalimumab, adecatumumab, belimumab, bertilimumab, denosumab, efungumab, golimumab, ipilimumab, iratumumab, lerdelimumab, lexatumumab, mapatumumab, metelimumab, ofatumumab, panitumumab, pritumumab, raxibacumab, sevirumab, stamulumab, ticilimumab, tuvirumab, votumumab, zalutumumab, zanolimumab, abciximab, basiliximab, bavituximab, cetuximab, ecromeximab, galiximab, infliximab, keliximab, lumiliximab, pagibaximab, priliximab, rituximab, teneliximab, volociximab, alemtuzumab, apolizumab, aselizumab, bapineuzumab, bevacizumab, bivatuzumab, cantuzumabmertansine, certolizumabpegol, daclizumab, eculizumab, efalizurnab, epratuzumab), fontolizumab, gemtuzumab, inotuzumabozogamicin, labetuzumab, lintuzumab, matuzumab, mepolizumab, motavizumab, natalizumab, nimotuzumab, ocrelizumab, omalizumab, palivizumab, pascolizumab, pertuzumab, pexelizumab, ranibizumab, reslizumab, rovelizumab, ruplizumab, sibrotuzumab, siplizumab, sontuzumab, tadocizumab, talizumab, tefibazumab, tocilizumab, toralizumab, trastuzumab, tucotuzumabcelmoleukin, urtoxazumab, visilizumab, yttrium (90Y)tacatuzumabtetraxetan, and IgG or combinations thereof.
The present invention involves the delivery of the mono clonal antibody delivery using the interchangeable primary drug container, the term MAB is not limited to the following or otherwise selected from wherein the monoclonal antibody is selected from the group consisting of: abagovomab, afelimomab, anatumomabmafenatox, arcitumomab, bectumomab, besilesomab, capromab, edobacomab, edrecolomab, elsilimomab, enlimomab, enlimomabpegol, epitumomabcituxetan, ibritumomabtiuxetan, imciromab, inolimomab, mitumomab, oregovomab, satumomab, sulesomab, technetium (.sup.99mTc) nofetumomabmerpentan, tositumomab, vepalimomab, zolimomabaritox, adalimumab, adecatumumab, belimumab, bertilimumab, denosumab, efungumab, golimumab, ipilimumab, iratumumab, lerdelimumab, lexatumumab, mapatumumab, metelimumab, ofatumumab, panitumumab, pritumumab, raxibacumab, sevirumab, stamulumab, ticilimumab, tuvirumab, votumumab, zalutumumab, zanolimumab, abciximab, basiliximab, bavituximab, cetuximabaecromeximab, galiximab, infliximab, keliximab, lumiliximab, pagibaximab, priliximab, rituximab, teneliximab, volociximab, alemtuzumab, apolizumab, aselizumab, bapineuzumab, bevacizumab, bivatuzumab, cantuzumabmertansine, certolizumabpegol, daclizumab, eculizumab, efalizumab, epratuzumab), fontolizumab, gemtuzumab, inotuzumabozogamicin, labetuzumab, lintuzumab, matuzumab, mepolizumab, motavizumab, natalizumab, nimotuzumab, ocrelizumab, omalizumab, palivizumab, pascolizumab, pertuzumab, pexelizumab, ranibizumab, reslizumab, rovelizumab, ruplizumab, sibrotuzumab, siplizumab, sontuzumab, tadocizumab, talizumab, tefibazumab, tocilizumab, toralizumab, trastuzumab, tucotuzumabcelmoleukin, urtoxazumab, visilizumab , yttrium .sup.90Y tacatuzumabtetraxetan, IgG-1, IgG-2, IgG-3, and IgG-4 or combinations thereof.
The term antibody refer to “Antibody” or “antibody peptide(s)” refer to an intact antibody, or a binding fragment thereof that competes with the intact antibody for specific binding. Binding fragments are produced by recombinant DNA techniques, or by enzymatic or chemical cleavage of intact antibodies. Binding fragments include Fab, Fab', F(ab')2, Fv, and single-chain antibodies. An antibody other than a “bispecific” or “bifunctional” antibody is understood to have each of its binding sites identical. An antibody substantially inhibits adhesion of a receptor to a counterreceptor when an excess of antibody reduces the quantity of receptor bound to counterreceptor by at least about 20%, 40%, 60% or 80%, and more usually greater than about 85% (as measured in an in vitro competitive binding assay).
The present invention involves the delivery of the mono clonal antibody delivery using the novel device, the term ‘polypeptide’ is not limited to the following or otherwise selected from wherein the Examples of polypeptides include insulin like growth factor-I (IGF-I or Somatomedin-C), insulin, calcitonin, leptin, hGH, human parathyroid hormone (PTH) or active fragments thereof, such as but not limited to PTH 1-31, PTH 1-34 and PTH 3-34, melatonin, GLP-1 or Glucagon-like peptide-1, GiP, OB-3 peptide, pituitary adenylate cyclase neuropeptide-activating polypeptide, GM-1 ganglioside, nerve growth factor (NGF), D-tryp6)-LHRH, nafarelin, FGF, VEGF, VEGF antagonists, Leuprolide, interferon-alpha, interferon-beta, interferon-gamma, low molecular weight heparin, PYY, LHRH, LH, GDNF, G-CSF, Ghrelin antagonists, Ghrelin, KGF,Integrelin, Nesiritide, cetrorelix acetate, ganirelix acetate, bivalirudin, zafirlukast, Exanitide, pramlintide acetate, vasopressin, desmopressin, glucagon, ACTH, GHRH and analogs, oxytocin, corticotropin releasing hormone, TRHrh, atrial natriuretic peptide, thyroxine releasing hormone, FSH, prolactin, Tobramycin, Triptorelin, Goserelin, Buserelin, Octreotide, Gonadorelin, Felypressin, Deslorelin, Vasopressin, 8-L-Arg, Eptifibatide, GM-CSF, EPO, Interleukin-11, Endostatin, Angiostatin, N-acetyl oxyntomodulin 30-37, Oxyntomodulin, Ularitide, Xerecept, Apo A-IV, rNAPc2, Secretin, Thymopentin, Neuromedin U, Neurotensin, Thrombospondin-1 inhibitors, FGF-18, FGF-20, FGF-21, Elcatonin Acetate, Antide Acetate, Dynorphin A (1-13) Acetate, Sincalide, Thymopentin Acetate, Thymosin alpha1 acetate (Thymalfasin), Fertirelin Acetate, CRF Acetate, CRF (ovine), Hisrelin, Thymalfasin, Ecallantide, Oxycortin, Urocortin, Spiegelmer nucleotide aptamers, CGRP (calcitonin gene related protein), Urocortin, Amylin, IL-21, melanotan, valpreotide, ACV-1 neuropathic pain peptide, gastrin, gastrin releasing peptide (GRP), gastrin releasing peptide-like peptides, or epidermal growth factor or combinations thereof.
The term HPMC (Hydroxyl propyl methyl cellulose) is not limited to an average molecular weight between about 10,000 and 13 million. Preferred cellulosic polymers include: hydroxypropyl methyl cellulose (HPMC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC) and methyl cellulose (MC). In general, these cellulosic polymers are present in the compositions of the present invention at a concentration between about 0.05 and about 5.0 percent by weight (wt%), preferably between about 0.25 and about 1.0 wt%. It is especially preferred to use the cellulosic polymers at a concentration of about 0.5 wt%.
The antibiotics include and not limited to Amikacin, Gentamicin, Kanamycin A, Neomycin, Netilmicin, Tobramycin, Paromomycin, Streptomycin, Spectinomycin, Geldanamycin, Rifaximin, Ertapenem, Doripenem, Imipenem, Meropenem , Cefadroxil, Cefazolin, Cefalexin, Clindamycin, Lincomycin, Daptomycin, Azithromycin, Erythromycin, Roxithromycin, Ampicillin/sulbactam, Ceftarolinefosamil, Nafcillin sodium, Norfloxacinetc and related compounds.
The present invention is also useful for the administration of Potential actives like Insulin, Heparin, Epinephrine, and Vitamin B-12 and not limited to former agents but also can be utilized for the administration of following agents.
The present invention is also suitable for the administration of pharmaceutical agents include, but are not limited to, anticancer agents or antineoplastics, antimicrotubule agents, immunosuppressive agents, anesthetics, hormones, agents for use in cardiovascular disorders, antiarrythmics, antibiotics, antifungals, antihypertensives, antiasthmatics, analgesics, anti-inflammatory agents, anti-arthritic agents, and vasoactive agents. The invention is useful with many other drug classes as well. More specifically, suitable pharmaceutical agents include, but are not limited to, taxanes, (e.g., Taxol® (paclitaxel), and Taxotere™ (docetaxel)), epothilones, camptothecin, colchicine, amiodarone, thyroid hormones, vasoactive peptides (e.g., vasoactive intestinal peptide), amphotericin, corticosteroids, propofol, melatonin, cyclosporine, rapamycin (sirolimus), tacrolimus, mycophenolic acids, ifosfamide, vinorelbine, vancomycin, gemcitabine, SU5416, thiotepa, bleomycin, diagnostic radiocontrast agents, and derivatives thereof.
Advantages:
1. Interchangeable drug container, specifically cartridge holder.
2. Can be used manually as well as electronically.
3. Obtained in a sterile package of combination of cartridge containing the therapeutics along with the cartridge holder affixed.
4. As sterile, can be used for ophthalmic purposes as well.
5. The stainless steel made plunger assembly can be autoclaved for ensuring sterility.
6. Is interchangeably driven manually as well as electronically with a simple coupling mechanism. The cartridge holder has teeth that can anchor the stainless steel plunger as well as the electronic pen injector.
7. If battery gets discharged, in case of electronic device, can be used manually thus the drug within cartridge will not be wasted.
8. Applicable for a wide range of field of application. It can be applied, but not limited to, dermal, ophthalmic, anesthetic, dental and various delivery purposes including insulin and so on.
The invention having been disclosed in connection with the foregoing embodiments, additional variations will now be apparent to persons skilled in the art. Various modifications and variations to the above described pen-injector can be made without departing from the scope of the invention.
From the foregoing it will be understood that the embodiments of the present invention described above are well suited to provide the advantages set forth, and since many possible embodiments may be made of the various features of this invention and as the device herein described may be varied in various parts, all without departing from the scope of the invention, it is to be understood that all matter hereinbefore set forth or shown in the accompanying drawings is to be interpreted as illustrative and that in certain instances some of the features may be used without a corresponding use of other features, all without departing from the scope of the invention.
Further the present invention has be illustrated in the different figures. The following specific and non-limiting steps for functioning need to be construed as merely illustrative, and do not limit the present disclosure in any way whatsoever.
Dated: Day 23rd, August, 2017
,CLAIMS:We Claim:
1. A single use interchangeable primary drug container wherein the container can be operated manually consisting of (i) a cartridge holder, (ii) a cartridge, (iii) a plunger assembly, and (iv) a needle.
2. A single use interchangeable primary drug container wherein the container can be operated electronically consisting of (i) a cartridge holder, (ii) a cartridge, (iii) a plunger assembly, and (iv) a needle.
3. A single use interchangeable primary drug container according to claim 1-2, wherein the container comprises of cartridge holder, made of plastic, more specifically thermoplastic, most specifically polyethylene, wherein the cartridge holder consists of teeth that embraces the plunger nut by a simple coupling mechanism; wherein the plunger nut being made of metal, more specifically stainless steel, that can be autoclaved for sterilization.
4. A single use interchangeable primary drug container according to claim 1-2, wherein the container comprises of a sterile package of a combination of cartridge holder and a cartridge that contains drug in the form of solution, suspension, and emulsion.
5. A single use interchangeable primary drug container according to claim 1-2, wherein the container comprises of a sterile package of a combination of cartridge holder and a cartridge that contains drug irrespective of viscous or non-viscous liquid.
6. A single use interchangeable primary drug container according to claim 1-2, wherein the container consists of a needle, with a tamper evident cap.
7. A single use interchangeable primary drug container according to claim 1-2, wherein the cartridge holder assembly can be operated manually as well as electronically based on the requirement.
| # | Name | Date |
|---|---|---|
| 1 | 201741031151-IntimationOfGrant26-03-2025.pdf | 2025-03-26 |
| 1 | 201741031151-STATEMENT OF UNDERTAKING (FORM 3) [02-09-2017(online)].pdf | 2017-09-02 |
| 1 | 201741031151-US(14)-HearingNotice-(HearingDate-19-12-2024).pdf | 2024-11-19 |
| 1 | 201741031151-Written submissions and relevant documents [01-01-2025(online)].pdf | 2025-01-01 |
| 2 | 201741031151-ABSTRACT [13-04-2023(online)].pdf | 2023-04-13 |
| 2 | 201741031151-AMENDED DOCUMENTS [09-12-2024(online)].pdf | 2024-12-09 |
| 2 | 201741031151-PatentCertificate26-03-2025.pdf | 2025-03-26 |
| 2 | 201741031151-PROVISIONAL SPECIFICATION [02-09-2017(online)].pdf | 2017-09-02 |
| 3 | 201741031151-CLAIMS [13-04-2023(online)].pdf | 2023-04-13 |
| 3 | 201741031151-Correspondence to notify the Controller [09-12-2024(online)].pdf | 2024-12-09 |
| 3 | 201741031151-POWER OF AUTHORITY [02-09-2017(online)].pdf | 2017-09-02 |
| 3 | 201741031151-Written submissions and relevant documents [01-01-2025(online)].pdf | 2025-01-01 |
| 4 | 201741031151-AMENDED DOCUMENTS [09-12-2024(online)].pdf | 2024-12-09 |
| 4 | 201741031151-COMPLETE SPECIFICATION [13-04-2023(online)].pdf | 2023-04-13 |
| 4 | 201741031151-FORM 1 [02-09-2017(online)].pdf | 2017-09-02 |
| 4 | 201741031151-FORM 13 [09-12-2024(online)].pdf | 2024-12-09 |
| 5 | 201741031151-POA [09-12-2024(online)].pdf | 2024-12-09 |
| 5 | 201741031151-DRAWINGS [02-09-2017(online)].pdf | 2017-09-02 |
| 5 | 201741031151-CORRESPONDENCE [13-04-2023(online)].pdf | 2023-04-13 |
| 5 | 201741031151-Correspondence to notify the Controller [09-12-2024(online)].pdf | 2024-12-09 |
| 6 | 201741031151-US(14)-HearingNotice-(HearingDate-19-12-2024).pdf | 2024-11-19 |
| 6 | 201741031151-FORM 13 [09-12-2024(online)].pdf | 2024-12-09 |
| 6 | 201741031151-DRAWING [13-04-2023(online)].pdf | 2023-04-13 |
| 6 | 201741031151-DECLARATION OF INVENTORSHIP (FORM 5) [02-09-2017(online)].pdf | 2017-09-02 |
| 7 | 201741031151-ABSTRACT [13-04-2023(online)].pdf | 2023-04-13 |
| 7 | 201741031151-FER_SER_REPLY [13-04-2023(online)].pdf | 2023-04-13 |
| 7 | 201741031151-POA [09-12-2024(online)].pdf | 2024-12-09 |
| 7 | Correspondence by Applicant_Submission Of Documents_13-09-2017.pdf | 2017-09-13 |
| 8 | 201741031151-CLAIMS [13-04-2023(online)].pdf | 2023-04-13 |
| 8 | 201741031151-DRAWING [23-08-2018(online)].pdf | 2018-08-23 |
| 8 | 201741031151-OTHERS [13-04-2023(online)].pdf | 2023-04-13 |
| 8 | 201741031151-US(14)-HearingNotice-(HearingDate-19-12-2024).pdf | 2024-11-19 |
| 9 | 201741031151-ABSTRACT [13-04-2023(online)].pdf | 2023-04-13 |
| 9 | 201741031151-COMPLETE SPECIFICATION [13-04-2023(online)].pdf | 2023-04-13 |
| 9 | 201741031151-CORRESPONDENCE-OTHERS [23-08-2018(online)].pdf | 2018-08-23 |
| 9 | 201741031151-FER.pdf | 2022-10-13 |
| 10 | 201741031151-CLAIMS [13-04-2023(online)].pdf | 2023-04-13 |
| 10 | 201741031151-COMPLETE SPECIFICATION [23-08-2018(online)].pdf | 2018-08-23 |
| 10 | 201741031151-CORRESPONDENCE [13-04-2023(online)].pdf | 2023-04-13 |
| 10 | 201741031151-FORM 18 [01-09-2021(online)].pdf | 2021-09-01 |
| 11 | 201741031151-COMPLETE SPECIFICATION [13-04-2023(online)].pdf | 2023-04-13 |
| 11 | 201741031151-COMPLETE SPECIFICATION [23-08-2018(online)].pdf | 2018-08-23 |
| 11 | 201741031151-DRAWING [13-04-2023(online)].pdf | 2023-04-13 |
| 11 | 201741031151-FORM 18 [01-09-2021(online)].pdf | 2021-09-01 |
| 12 | 201741031151-CORRESPONDENCE [13-04-2023(online)].pdf | 2023-04-13 |
| 12 | 201741031151-CORRESPONDENCE-OTHERS [23-08-2018(online)].pdf | 2018-08-23 |
| 12 | 201741031151-FER.pdf | 2022-10-13 |
| 12 | 201741031151-FER_SER_REPLY [13-04-2023(online)].pdf | 2023-04-13 |
| 13 | 201741031151-OTHERS [13-04-2023(online)].pdf | 2023-04-13 |
| 13 | 201741031151-DRAWING [23-08-2018(online)].pdf | 2018-08-23 |
| 13 | 201741031151-DRAWING [13-04-2023(online)].pdf | 2023-04-13 |
| 14 | 201741031151-FER.pdf | 2022-10-13 |
| 14 | 201741031151-FER_SER_REPLY [13-04-2023(online)].pdf | 2023-04-13 |
| 14 | Correspondence by Applicant_Submission Of Documents_13-09-2017.pdf | 2017-09-13 |
| 15 | 201741031151-DECLARATION OF INVENTORSHIP (FORM 5) [02-09-2017(online)].pdf | 2017-09-02 |
| 15 | 201741031151-DRAWING [13-04-2023(online)].pdf | 2023-04-13 |
| 15 | 201741031151-FORM 18 [01-09-2021(online)].pdf | 2021-09-01 |
| 15 | 201741031151-OTHERS [13-04-2023(online)].pdf | 2023-04-13 |
| 16 | 201741031151-COMPLETE SPECIFICATION [23-08-2018(online)].pdf | 2018-08-23 |
| 16 | 201741031151-CORRESPONDENCE [13-04-2023(online)].pdf | 2023-04-13 |
| 16 | 201741031151-DRAWINGS [02-09-2017(online)].pdf | 2017-09-02 |
| 16 | 201741031151-FER.pdf | 2022-10-13 |
| 17 | 201741031151-FORM 1 [02-09-2017(online)].pdf | 2017-09-02 |
| 17 | 201741031151-FORM 18 [01-09-2021(online)].pdf | 2021-09-01 |
| 17 | 201741031151-COMPLETE SPECIFICATION [13-04-2023(online)].pdf | 2023-04-13 |
| 17 | 201741031151-CORRESPONDENCE-OTHERS [23-08-2018(online)].pdf | 2018-08-23 |
| 18 | 201741031151-DRAWING [23-08-2018(online)].pdf | 2018-08-23 |
| 18 | 201741031151-POWER OF AUTHORITY [02-09-2017(online)].pdf | 2017-09-02 |
| 18 | 201741031151-COMPLETE SPECIFICATION [23-08-2018(online)].pdf | 2018-08-23 |
| 18 | 201741031151-CLAIMS [13-04-2023(online)].pdf | 2023-04-13 |
| 19 | 201741031151-ABSTRACT [13-04-2023(online)].pdf | 2023-04-13 |
| 19 | 201741031151-CORRESPONDENCE-OTHERS [23-08-2018(online)].pdf | 2018-08-23 |
| 19 | 201741031151-PROVISIONAL SPECIFICATION [02-09-2017(online)].pdf | 2017-09-02 |
| 19 | Correspondence by Applicant_Submission Of Documents_13-09-2017.pdf | 2017-09-13 |
| 20 | 201741031151-DECLARATION OF INVENTORSHIP (FORM 5) [02-09-2017(online)].pdf | 2017-09-02 |
| 20 | 201741031151-DRAWING [23-08-2018(online)].pdf | 2018-08-23 |
| 20 | 201741031151-STATEMENT OF UNDERTAKING (FORM 3) [02-09-2017(online)].pdf | 2017-09-02 |
| 20 | 201741031151-US(14)-HearingNotice-(HearingDate-19-12-2024).pdf | 2024-11-19 |
| 21 | 201741031151-DRAWINGS [02-09-2017(online)].pdf | 2017-09-02 |
| 21 | 201741031151-POA [09-12-2024(online)].pdf | 2024-12-09 |
| 21 | Correspondence by Applicant_Submission Of Documents_13-09-2017.pdf | 2017-09-13 |
| 22 | 201741031151-DECLARATION OF INVENTORSHIP (FORM 5) [02-09-2017(online)].pdf | 2017-09-02 |
| 22 | 201741031151-FORM 1 [02-09-2017(online)].pdf | 2017-09-02 |
| 22 | 201741031151-FORM 13 [09-12-2024(online)].pdf | 2024-12-09 |
| 23 | 201741031151-Correspondence to notify the Controller [09-12-2024(online)].pdf | 2024-12-09 |
| 23 | 201741031151-DRAWINGS [02-09-2017(online)].pdf | 2017-09-02 |
| 23 | 201741031151-POWER OF AUTHORITY [02-09-2017(online)].pdf | 2017-09-02 |
| 24 | 201741031151-AMENDED DOCUMENTS [09-12-2024(online)].pdf | 2024-12-09 |
| 24 | 201741031151-FORM 1 [02-09-2017(online)].pdf | 2017-09-02 |
| 24 | 201741031151-PROVISIONAL SPECIFICATION [02-09-2017(online)].pdf | 2017-09-02 |
| 25 | 201741031151-POWER OF AUTHORITY [02-09-2017(online)].pdf | 2017-09-02 |
| 25 | 201741031151-STATEMENT OF UNDERTAKING (FORM 3) [02-09-2017(online)].pdf | 2017-09-02 |
| 25 | 201741031151-Written submissions and relevant documents [01-01-2025(online)].pdf | 2025-01-01 |
| 26 | 201741031151-PatentCertificate26-03-2025.pdf | 2025-03-26 |
| 26 | 201741031151-PROVISIONAL SPECIFICATION [02-09-2017(online)].pdf | 2017-09-02 |
| 27 | 201741031151-STATEMENT OF UNDERTAKING (FORM 3) [02-09-2017(online)].pdf | 2017-09-02 |
| 27 | 201741031151-IntimationOfGrant26-03-2025.pdf | 2025-03-26 |
| 1 | searchstrategy(14)E_12-10-2022.pdf |