CA2706272C - Multi phase soft gel capsules, apparatus and method thereof - Google Patents

Multi phase soft gel capsules, apparatus and method thereof Download PDF

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Publication number
CA2706272C
CA2706272C CA2706272A CA2706272A CA2706272C CA 2706272 C CA2706272 C CA 2706272C CA 2706272 A CA2706272 A CA 2706272A CA 2706272 A CA2706272 A CA 2706272A CA 2706272 C CA2706272 C CA 2706272C
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Canada
Prior art keywords
dosage form
guide roller
capsule
solid dosage
rotary die
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CA2706272A
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French (fr)
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CA2706272A1 (en
Inventor
Peter Draper
James Draper
Beth Okutan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Catalent Ontario Ltd
Original Assignee
Catalent Ontario Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to CA2706272A priority Critical patent/CA2706272C/en
Application filed by Catalent Ontario Ltd filed Critical Catalent Ontario Ltd
Priority to CA3065589A priority patent/CA3065589C/en
Priority to MX2016016430A priority patent/MX389324B/en
Priority to PT11789015T priority patent/PT2575788T/en
Priority to JP2013512708A priority patent/JP2013528439A/en
Priority to EP11789015.2A priority patent/EP2575788B1/en
Priority to EP23200264.2A priority patent/EP4327797A3/en
Priority to DK11789015.2T priority patent/DK2575788T3/en
Priority to US13/701,461 priority patent/US9844512B2/en
Priority to EP18187807.5A priority patent/EP3446687A1/en
Priority to ES11789015T priority patent/ES2703731T3/en
Priority to TR2018/20134T priority patent/TR201820134T4/en
Priority to HUE11789015A priority patent/HUE041467T2/en
Priority to PCT/CA2011/000651 priority patent/WO2011150506A1/en
Priority to SI201131641T priority patent/SI2575788T1/en
Priority to MX2012013930A priority patent/MX2012013930A/en
Priority to AU2011261118A priority patent/AU2011261118B2/en
Publication of CA2706272A1 publication Critical patent/CA2706272A1/en
Priority to JP2016029926A priority patent/JP6321060B2/en
Priority to AU2016253596A priority patent/AU2016253596A1/en
Priority to US15/802,315 priority patent/US11173125B2/en
Priority to JP2018024000A priority patent/JP6586477B2/en
Priority to AU2018275028A priority patent/AU2018275028B2/en
Priority to CY20181101392T priority patent/CY1121301T1/en
Priority to JP2019163730A priority patent/JP7381260B2/en
Application granted granted Critical
Publication of CA2706272C publication Critical patent/CA2706272C/en
Priority to US17/526,631 priority patent/US20220142931A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P20/00—Coating of foodstuffs; Coatings therefor; Making laminated, multi-layered, stuffed or hollow foodstuffs
    • A23P20/10—Coating with edible coatings, e.g. with oils or fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/074—Filling capsules; Related operations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/077—Manufacturing capsule shells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Polymers & Plastics (AREA)
  • Food Science & Technology (AREA)
  • Nutrition Science (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Obesity (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (AREA)
  • Urology & Nephrology (AREA)
  • Pulmonology (AREA)
  • Rheumatology (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

A multi phase soft gelatin dosage form comprising at least one preformed solid dosage form and at least one liquid fill phase. The multi phase soft gelatin dosage forms of the present invention are especially useful to combine at least one solid dosage form and at least one liquid phase for single ingestion. Method and apparatus for manufacturing the multi phase soft gelatin dosage forms are also described. The solid phase, liquid phase or coatings may comprise active pharmaceutical ingredients, nutraceuticals, nutritional supplements, therapeutic substances, functional excipients or combinations thereof.

Description

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MULTI PHASE SOFT GEL CAPSULES, APPARATUS AND METHOD THEREOF
The present invention generally relates to a soft gel capsule which contains particles in a liquid vehicle. More particularly, the present invention relates to soft gel capsules derived from encapsulation of one or more liquid phases and at least one solid phase. The phases may be .. formulations of active pharmaceutical ingredients (API), nutritional supplements, or substances used for therapeutic or cosmetic skin care purposes.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG.1 is a side cross-sectional view of an embodiment of the multi-phase apparatus.
FIG. 2 is a perspective view of soft gel capsules according to the invention.
DETAILED DESCRIPTION
An improved process and apparatus for encapsulating soft gelatin dosage capsules capable of incorporating one or more fluid or liquid phases and at least one solid phase independently of one another is disclosed. Figure 1 illustrates an apparatus 10 for manufacture of soft gel capsules containing one or more fluid or liquid phases and at least one solid phase.
The apparatus 10 may be a rotary die soft gel encapsulation machine similar to those known in the art. Unlike conventional rotary die soft gel encapsulation machines which have two die rolls, the apparatus 10 has four die rolls 12, 14, 16, 18. Solid dosage forms 30 formed by conventional means, such as tablets, caplets or capsules, are housed in a hopper 32 positioned above a guide roll 16. The hopper 32 releases a single solid dosage form 30 into each pocket of the guide roll 16. The solid dosage form 30 is then deposited into a preformed gel ribbon pocket 22 forming the first half of a soft gel capsule. A shield 50 retains the single solid dosage form 30 in the pockets of the guide roll 16 or gel ribbon pocket 22.
The gel ribbon pockets 22 are preformed on one gel ribbon 20a between a ribbon guide roller 18, and a rotary die 14. The gel ribbon pockets 22 which contain a solid dosage form 30 are filled by injecting a liquid phase 34 housed in the liquid hopper 36 via a wedge 38.
Simultaneously, the second half of a soft gel capsule is formed on a second gel ribbon 20b between die rolls 12, 14 and the first and second halves of a soft gel capsule are sealed to form a single soft gel capsule 40. The second half of a soft gel capsule is formed in a conventional manner, such as by a press or vacuum.

Figure 2 illustrates soft gel capsules 40 made in accordance with the invention containing a solid tablet 30. These soft gel capsules are approximately 15mm by lOmm in size.
The apparatus may be adapted to any single or multiple channel soft gel encapsulation machine of any rotary die configuration to incorporate solid dosage forms into a soft gel capsule.
The shell of the soft gel capsule may be formed from plasticized gelatin or other functional polymeric materials that are typically used for encapsulation of liquids, fluids, pastes or other fill materials. Each of the liquid and solid phases may contain one or more active ingredients, functional excipients or combinations of active ingredients and functional excipients that control or otherwise affect the release of the active pharmaceutical ingredient(s) into the gastrointestinal tract or site of administration. The fill materials may also include excipients known in the art of soft gel encapsulation such as dispersants, surfactants, plasticizers, flavoring agents, opacifying agents, preservatives, embrittlement inhibiting agents, colorants, dyes and pigments, and disintegrants. The solid phase may be in the form of preformed tablets, caplets, capsules, slugs of solid materials, granules or other solid forms.
Soft gel capsules containing solid and liquid phases according to the invention provides a number of significant benefits for the administration of active pharmaceutical ingredients (APIs).
When two or more capsules and or tablets are prescribed, their combination into one dosage form provides patient benefits and administration advantages of convenience and costs.
The present invention may provide effective control of the release of single or multiple APIs. The liquid phase provides the capability of immediate release of the API
by virtue of a solution, pre-dispersed or self-emulsifying formulation. The solid phase may be film coated or coated to delay the release of the API.
The present invention may reduce the problems, such as time and expense, associated with combining two or more APIs into one dosage form. New combinations in one dosage form require development of a new formulation and the attendant pharmaceutical and clinical studies required to demonstrate safety, efficacy and potency. The present invention provides the capability to incorporate more than one API into a unit dosage form utilizing established forms of the API or APIs that may be in liquid or solid phases. The present invention allows retention of the established tablet, caplet or capsule form of an API. This provides the capability to retain the pharmaceutical characteristics of the solid dosage form in combination with a liquid or fluid
2 =
phase. Key characteristics include: physical and chemical stability, API
release profile of the tablet or caplet, bioavailability and clinical performance. Retention of the established clinical performance by incorporation of the original solid may avoid the need to conduct extensive Phase Ill clinical studies that would otherwise be required with a new formulation.
The following are examples of the benefits of the present invention for the administration of combinations of medicines that may be in the form of a tablet, caplet, capsule or granule in a soft gel.
The present invention may be useful for the combined administration of unit doses of HMG-CoA inhibitors (statins) and Omega-3 fatty acids. The statins may be in the form of tablets or capsules containing single ingredient HMG-CoA inhibitors, or statins in combination with other active ingredients. Commercially available statins include LIPITORTm or TORVASTTm (atorvastatin calcium) sold by Pfizer, LESCOLTM or LESCOL XLTM (fluvastatin sodium) sold by Novartis, MEVACORTM, ALTOCORTm or ALTOPREVTm (lovastatin) sold by Merck, LIVALOTM or PITAVATm (pitavastatin) sold by Kowa, PRAVACHOLTM, SELEKTINETm or LIPOSTATTm (pravastatin sodium) sold by Bristol Myers Squibb, CRESTOR TM (rosuvastatin calcium) sold by AstraZeneca, ZOCORTM or LIPEXTM (simvastatin) sold by Merck, VYORTINTm (simvastatin +
exetimibe) sold by Merck, ADVICORTM (lovatatin + niacin) sold by Merck, CADUETTm (atorvastatin calcium and amlodipine besylate) sold by Pfizer, and SIMCORTm (simvastatin +
niacin) sold by Merck. The Omega-3 fatty acids may be in the form of ethyl esters or tri-glycerides.
The present invention may be useful as a polypill. A polypill is a medication that contains a combination of active ingredients reducing the number of tablets or capsules that need to be taken. Combined medications in the form of a polypill are useful for the treatment of cardiovascular disease and diabetes.
By combining a number of established, off patent or generic medications, the present invention may be useful to treat cardiovascular conditions and provides the prospect of low cost treatment.
In view of the teachings presented herein, other modifications and variations of the present inventions will be readily apparent to those of skill in the art. The foregoing discussion and description are illustrative of some embodiments of the present invention, but are not meant to be limitations on the practice thereof.
3 Any patents or publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains.
4

Claims (5)

What is claimed is:
1. An apparatus for manufacturing multiple phase soft gelatin capsules having at least one preformed solid dosage form and at least one liquid phase encapsulated between two gelatin strips, said apparatus comprising:
first and second cylindrical rotary dies for forming soft gelatin capsules from two gelatin strips, the dies having a plurality of recesses each of which is cooperable with a recess of similar size in the other die to form a cavity for filling and sealing one soft gelatin capsule, the first rotary die having a first axis of rotation and a first vertical axis passing through the first axis of rotation, and the second rotary die having a second axis of rotation and a second vertical axis passing through the second axis of rotation;
a ribbon guide roller located adjacent to the first rotary die for feeding a first gelatin strip to the first rotary die between the ribbon guide roller and the first rotary die, the ribbon guide roller having a plurality of projections each of which is cooperable with a recess of similar size in the first rotary die to form a tablet receiving depression in the first gelatin strip, the depression forming a first half of a soft gelatin capsule shell;
a dosage form guide roller having an axis of rotation and a vertical axis passing through the axis of rotation of the guide roller that is offset from the first and second vertical axes of the first and second rotary dies, the dosage form guide roller located above and adjacent to one side of the first rotary die to receive the first gelatin strip having a the tablet receiving depression, the dosage form guide roller having a plurality of recesses each of which is cooperable with a recess of similar size in the first rotary die to form a cavity to deposit the preformed solid dosage form into the tablet receiving depression in the first gelatin strip, and wherein the plurality of recesses are sized to receive the preformed solid dosage form from a dispenser located above the dosage form guide roller;
a feed means for delivering a second gelatin strip to the second rotary die;
means for forming a depression in the second gelatin strip to form a second half of the soft gelatin capsule shell; and at least one filling means located above said first and second cylindrical rotary dies for delivering at least one liquid phase through at least one nozzle to the soft gelatin capsule;
wherein the at least one preformed solid dosage form and the at least one liquid phase are independently introduced in the soft gelatin capsule, and wherein the at least one preformed solid dosage form is a tablet, caplet or capsule.
2. The apparatus of claim 1, further comprising a shield positioned adjacent to the dosage form guide roller to retain the preformed solid dosage form in the recesses of the dosage form guide roller.
3. The apparatus of claim 1, wherein the dispenser is a hopper.
4. A method for the encapsulation of at least one preformed solid dosage form and at least one liquid phase in a soft gelatin capsule, comprising the steps of:
feeding a gelatin strip to a rotary die with a ribbon guide roller;
forming a first capsule shell part in the gelatin strip between a projection of the ribbon guide roller and a recess of the rotary die;
providing a first capsule shell part;
introducing at least one preformed solid dosage form in the first capsule shell part;
providing a second capsule shell part;
moving the first and second capsule shell parts together at an end to form a cavity;
introducing at least one liquid phase into the cavity; and sealing the first and second capsule shell parts to form the soft gelatin capsule;
wherein the at least one preformed solid dosage form and the at least one liquid phase are independently introduced in the soft gelatin capsule.
5. The method according to claim 4, wherein the at least one preformed solid dosage form is selected from the group consisting of a tablet, a caplet, a capsule, a slug of solid material and a granule.
CA2706272A 2010-06-03 2010-06-03 Multi phase soft gel capsules, apparatus and method thereof Active CA2706272C (en)

Priority Applications (25)

Application Number Priority Date Filing Date Title
CA3065589A CA3065589C (en) 2010-06-03 2010-06-03 Multi phase soft gel capsules, apparatus and method thereof
CA2706272A CA2706272C (en) 2010-06-03 2010-06-03 Multi phase soft gel capsules, apparatus and method thereof
MX2012013930A MX2012013930A (en) 2010-06-03 2011-06-03 Multi phase soft gel capsules, apparatus and method thereof.
JP2013512708A JP2013528439A (en) 2010-06-03 2011-06-03 Multi-phase soft gel capsule, apparatus and method thereof
EP11789015.2A EP2575788B1 (en) 2010-06-03 2011-06-03 Multi phase soft gel capsules, apparatus and method thereof
EP23200264.2A EP4327797A3 (en) 2010-06-03 2011-06-03 Multi phase soft gel capsules, apparatus and method thereof
DK11789015.2T DK2575788T3 (en) 2010-06-03 2011-06-03 Soft multiphase gel capsules, device and method thereof
US13/701,461 US9844512B2 (en) 2010-06-03 2011-06-03 Multi phase soft gel capsules, apparatus and method thereof
EP18187807.5A EP3446687A1 (en) 2010-06-03 2011-06-03 Multi phase soft gel capsules, apparatus and method thereof
ES11789015T ES2703731T3 (en) 2010-06-03 2011-06-03 Multiphase soft gel capsules, devices and method of these
TR2018/20134T TR201820134T4 (en) 2010-06-03 2011-06-03 MULTI PHASE SOFT GEL CAPSULES, APPARATUS AND RELATED METHODS.
HUE11789015A HUE041467T2 (en) 2010-06-03 2011-06-03 Multi phase soft gel capsules, apparatus and method thereof
MX2016016430A MX389324B (en) 2010-06-03 2011-06-03 MULTI-PHASE SOFT GEL CAPSULES, APPARATUS AND METHOD THEREOF.
SI201131641T SI2575788T1 (en) 2010-06-03 2011-06-03 Multi phase soft gel capsules, apparatus and method thereof
PT11789015T PT2575788T (en) 2010-06-03 2011-06-03 Multi phase soft gel capsules, apparatus and method thereof
AU2011261118A AU2011261118B2 (en) 2010-06-03 2011-06-03 Multi phase soft gel capsules, apparatus and method thereof
PCT/CA2011/000651 WO2011150506A1 (en) 2010-06-03 2011-06-03 Multi phase soft gel capsules, apparatus and method thereof
JP2016029926A JP6321060B2 (en) 2010-06-03 2016-02-19 Multi-phase soft gel capsule, apparatus and method thereof
AU2016253596A AU2016253596A1 (en) 2010-06-03 2016-11-02 Multi phase soft gel capsules, apparatus and method thereof
US15/802,315 US11173125B2 (en) 2010-06-03 2017-11-02 Multiphase soft gel capsules, apparatus and method thereof
JP2018024000A JP6586477B2 (en) 2010-06-03 2018-02-14 Multi-phase soft gel capsule, apparatus and method thereof
AU2018275028A AU2018275028B2 (en) 2010-06-03 2018-12-10 Multi phase soft gel capsules, apparatus and method thereof
CY20181101392T CY1121301T1 (en) 2010-06-03 2018-12-21 MULTIPH-PHASE SOFT CAPSULES, DEVICE AND METHOD
JP2019163730A JP7381260B2 (en) 2010-06-03 2019-09-09 Multi-phase soft gel capsule, device and method thereof
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