MULTI PHASE SOFT GEL CAPSULES, APPARATUS AND METHOD THEREOF

• US 20130136792A1
• Filed: 06/03/2011
• Published: 05/30/2013
• Est. Priority Date: 06/03/2010
• Status: Active Grant

• Current Assignee: Catalent Ontario Ltd. (Catalent, Inc.)
• Original Assignee: Accucaps Industries Ltd. (Catalent, Inc.)
• Inventors: Draper, Peter, Okutan, Beth Marie, Draper, James Edward
• Granted Patent: US 9,844,512 B2
• Time in Patent Office: Days
• US Class Current: 424/452
• CPC Class Codes: A23P 20/10 Coating with edible coatings, e.g. with oils or fats
• CPC Class Codes: A61J 3/07 into the form of capsules or similar small containers for oral use
• CPC Class Codes: A61J 3/071 into the form of telescopically engaged two-piece capsules
• CPC Class Codes: A61J 3/074 Filling capsules; Related operations
• CPC Class Codes: A61J 3/077 Manufacturing capsule shells
• CPC Class Codes: A61K 31/196 the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
• CPC Class Codes: A61K 31/4545 containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/28 Dragees; Coated pills or tablets , e.g. with film or compression coating A61K9/2072 takes precedence, e.g. partially coated tablets A61K9/2072, coated multilayer tablets A61K9/2086, tablets with drug-coated core A61K9/209
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61K 9/4816 Wall or shell material
• CPC Class Codes: A61K 9/4825 Proteins, e.g. gelatin gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816
• CPC Class Codes: A61K 9/4891 Coated capsules; Multilayered drug free capsule shells with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 13/08 of the prostate
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/12 : Antihypertensives

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 multiphase 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.

Claims

1-28. -28. (canceled)

29. 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;

a ribbon guide roller located adjacent to the first rotary die for feeding a first gelatin strip to 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 located adjacent to the first rotary die, 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.

30. The apparatus of claim 29, 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.

31. The apparatus of claim 29, wherein the dispenser is selected from the group consisting of a hopper, a chute, a ramp and a feed funnel.

32. 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:

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.

33. The method according to claim 32, 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.

34. A multi phase soft gelatin capsule for oral administration, the soft gelatin capsule comprising:

at least one preformed solid dosage form comprising at least one active ingredient; and

at least one liquid fill phase;

wherein the at least one solid dosage form and the at least one liquid fill phase are independently introduced in the soft gelatin capsule.

35. The soft gelatin capsule according to claim 34, wherein the at least one preformed solid dosage form is a pharmaceutical grade finished dosage form.

36. The soft gelatin capsule according to claim 34, 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.

37. The soft gelatin capsule according to claim 34, wherein the at least one active ingredient in the at least one preformed solid dosage form is selected from the group consisting of:

an active pharmaceutical ingredient, nutraceutical, nutritional supplement, therapeutic substance, functional excipients and combinations thereof.

38. The soft gelatin capsule according to claim 34, wherein the at least one liquid fill phase is lipophilic or hydrophilic.

39. The soft gelatin capsule according to claim 34, wherein the at least one liquid fill phase comprises diluent oils.

40. The soft gelatin capsule according to claim 34, wherein the at least one liquid fill phase comprises vegetable oils, mineral oils, food grade oils, pharmaceutically acceptable oils or mixtures thereof.

41. The soft gelatin capsule according to claim 34, wherein the at least one liquid fill phase further comprises at least one active ingredient.

42. The soft gelatin capsule according to claim 34, wherein the at least one liquid fill phase further comprises at least one active ingredient selected from the group consisting of:

an active pharmaceutical ingredient, nutraceutical, nutritional supplement, therapeutic substance, functional excipients and combinations thereof.

43. The soft gelatin capsule according to claim 34, wherein the active pharmaceutical ingredient in the at least one preformed solid dosage form is an aspirin tablet, and wherein the at least one liquid fill phase further comprises at least one active ingredient that is Omega-3 oil.

44. The soft gelatin capsule according to claim 34, wherein the active pharmaceutical ingredient in the at least one preformed solid dosage form is an acetaminophen tablet, and wherein the at least one liquid fill phase further comprises at least one active ingredient selected from the group consisting of:

codeine, codeine phosphate, codeine sulphate, caffeine, hydrocodone, acetylsalicylic acid, pseudoephedrine hydrochloride, pseudoephedrine sulphate, brompheniramine maleate, chlorcyclizine hydrochloride, chlorpheniramine maleate, dexbrompheniramine maleate, dexchlorpheniramine maleate, diphenhydramine hydrochloride, diphenhydramine citrate, doxylamine succinate, phenindamine tartrate, pheniramine maleate, pyrilamine maleate, triprolidine hydrochloride, dextromethorphan hydrobromide, guaiphenesin, phenylephrine hydrochloride, acetaminophen and combinations thereof.

45. The soft gelatin capsule according to claim 34, wherein the active pharmaceutical ingredient in the at least one preformed solid dosage form is an acetaminophen tablet, and wherein the at least one liquid fill phase further comprises at least one active ingredient that is acetaminophen.

46. The soft gelatin capsule according to claim 34, wherein the active pharmaceutical ingredient in the at least one preformed solid dosage form is an ibuprofen tablet, and wherein the at least one liquid fill phase further comprises at least one active ingredient that is ibuprofen.

47. The soft gelatin capsule according to claim 34, wherein the active pharmaceutical ingredient in the at least one preformed solid dosage form is a pseudoephedrine caplet, and wherein the at least one liquid fill phase further comprises at least one active ingredient that is loratadine.

48. The soft gelatin capsule according to claim 34, wherein the at least one preformed solid dosage form has at least one coating.

49. The soft gelatin capsule according to claim 34, wherein the at least one preformed solid dosage form has at least one coating selected from the group consisting of:

immediate release coatings, protective coatings, enteric or delayed release coatings, sustained release coating, barrier coatings, moisture shield coatings and combinations thereof.

50. The soft gelatin capsule according to claim 34, wherein the at least one preformed solid dosage form has at least one coating selected from the group consisting of:

film coating, gelatin coating and combinations thereof.

51. The soft gelatin capsule according to claim 34, wherein the at least one preformed solid dosage form has at least one coating, the at least one coating further comprises at least one active ingredient.

52. The soft gelatin capsule according to claim 34, wherein the at least one preformed solid dosage form has at least one coating, the at least one coating further comprising at least one active ingredient selected from the group consisting of:

an active pharmaceutical ingredient, nutraceutical, nutritional supplement, therapeutic substance, functional excipients and combinations thereof.

53. The soft gelatin capsule according to claim 34, wherein the soft gelatin capsule has at least one coating.

54. The soft gelatin capsule according to claim 34, wherein the soft gelatin capsule has at least one coating selected from the group consisting of:

immediate release coatings, protective coatings, enteric or delayed release coatings, sustained release coating, barrier coatings and combinations thereof.

55. The soft gelatin capsule according to claim 34, wherein the soft gelatin capsule has at least one coating, the at least one coating further comprising at least one active ingredient.

56. The soft gelatin capsule according to claim 34, wherein the soft gelatin capsule has at least one coating, the at least one coating further comprising at least one active ingredient selected from the group consisting of:

an active pharmaceutical ingredient, nutraceutical, nutritional supplement, therapeutic substance, functional excipients and combinations thereof.