COATED PHARMACEUTICAL CAPSULE DOSAGE FORM

• US 20100291201A1
• Filed: 05/14/2009
• Published: 11/18/2010
• Est. Priority Date: 05/14/2009
• Status: Abandoned Application

• Current Assignee: Cerovene Incorporated
• Original Assignee: Cerovene Incorporated
• Inventors: SHAH, Manish S., Difalco, Ray J.
• Application Number:
  US12/466,261
• Publication Number:
  US 20100291201A1
• Time in Patent Office: Days
• US Class Current: 424/456
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/415 1,2-Diazoles
• CPC Class Codes: A61K 31/4439 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole nicotine A61K31/465
• CPC Class Codes: A61K 31/454 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
• CPC Class Codes: A61K 31/65 Tetracyclines
• 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: A61K 9/5015 Organic compounds, e.g. fats, sugars
• CPC Class Codes: A61K 9/5078 with drug-free core
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 15/10 for impotence
• CPC Class Codes: A61P 21/02 Muscle relaxants, e.g. for tetanus or cramps
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/06 Antimigraine agents
• CPC Class Codes: A61P 25/08 Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 25/24 Antidepressants
• 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 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/10 : Antimycotics
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 33/02 : Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
• CPC Class Codes: A61P 33/06 : Antimalarials
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 5/24 : of the sex hormones
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/12 : Antihypertensives

Abstract

Pharmaceutical compositions in unit dose form comprising a hard or soft capsule containing a fill consisting of one or more inert ingredients, and one or more coatings on the capsule, wherein at least one coating comprises at least one active pharmaceutical ingredient.

Claims

1. A pharmaceutical composition in unit dose form comprising:

(a) a hard or soft capsule containing a fill consisting of one or more inert ingredients in a pharmaceutically acceptable vehicle and wherein the fill does not contain an active pharmaceutical ingredient; and

(b) one or more coatings on the hard or soft capsule, wherein at least one coating comprises at least one active pharmaceutical ingredient, and

wherein one or more inert ingredients in the fill increase oral bioavailability, increase solubility, or delay or sustain release of one or more of the at least one active pharmaceutical ingredient.

2. The pharmaceutical composition of claim 1, further comprising at least one additional coating between the capsule and the at least one coating comprising the at least one active pharmaceutical ingredient.

3. The pharmaceutical composition of claim 2, wherein the at least one additional coating is selected from the group consisting of immediate release coatings, protective coatings, enteric or delayed release coatings, sustained release coatings, barrier coatings, seal coatings, and combinations thereof.

4. The pharmaceutical composition of claim 1, further comprising at least one top coating on the at least one coating comprising the at least one active pharmaceutical ingredient.

5. The pharmaceutical composition of claim 4, wherein the at least one top coating is selected from the group consisting of immediate release coatings, protective coatings, enteric or delayed release coatings, sustained release coatings, barrier coatings, seal coatings, and combinations thereof.

6. The pharmaceutical composition of claim 1, further comprising at least one barrier coating between the capsule and the at least one coating comprising the at least one active pharmaceutical ingredient, and at least one top coating selected from the group consisting of enteric or delayed release coatings, protective coatings, or combinations thereof, on the at least one coating comprising the at least one active pharmaceutical ingredient.

7. The pharmaceutical composition of claim 1, wherein the active pharmaceutical ingredient is selected from the group consisting of analgesics, anti-inflammatory agents, anti-helminthics, anti-arrhythmic agents, anti-asthma agents, anti-bacterial agents, anti-viral agents, anti-coagulants, anti-dementia agents, anti-depressants, anti-diabetics, anti-epileptics, anti-fungal agents, anti-gout agents, anti-hypertensive agents, anti-malarials, anti-migraine agents, anti-muscarinic agents, anti-neoplastic agents, immunosuppressants, anti-protozoal agents, anti-thyroid agents, anti-tussives, anxiolytics, sedatives, hypnotics, neuroleptics, neuroprotective agents, β

-blockers, cardic inotropic agents, cell adhesion inhibitors, corticosteroids, cytokine receptor activity modulators, diuretics, anti-parkinsonian agents, gastrointestinal agents, histamine H-receptor antagonists, keratolytics, lipid regulating agents, muscle relaxants, nitrates and other anti-anginal agents, non-steroid anti-asthma agents, nutritional agents, opioid analgesics, sex hormones, stimulants and anti-erectile dysfunction agents, and combinations thereof.

8. The pharmaceutical composition of claim 7, wherein the active pharmaceutical ingredient is selected from the group consisting of fenofibrate, doxycycline, omeprazole, dutasteride, celecoxib, thalidomide, and salts thereof.

9. The pharmaceutical composition of claim 1, wherein the dosage form is suitable for oral administration.

10. The pharmaceutical composition of claim 1, wherein the capsule is a soft gelatin capsule.

11. The pharmaceutical composition of claim 1, wherein the at least one coating comprising the at least one active pharmaceutical ingredient is applied by spray coating.

12. A method of treating, preventing or reducing the occurrence of a condition in a subject, comprising administering to the subject the pharmaceutical composition of claim 1.

13. The method of claim 12, wherein the condition is selected from the group consisting of:

gastrointestinal conditions, cardiovascular conditions, and pain-related conditions.

14. A pharmaceutical composition in unit dose form comprising:

(a) a hard or soft capsule containing a fill consisting of one or more inert ingredients in a pharmaceutically acceptable vehicle, and wherein the fill does not contain an active pharmaceutical ingredient; and

(b) one or more coatings on the hard or soft capsule, wherein at least one coating comprises at least one active pharmaceutical ingredient.

15. The pharmaceutical composition of claim 14, further comprising at least one additional coating between the capsule and the at least one coating comprising the at least one active pharmaceutical ingredient.

16. The pharmaceutical composition of claim 15, wherein the at least one additional coating is selected from the group consisting of immediate release coatings, protective coatings, enteric or delayed release coatings, sustained release coatings, barrier coatings, seal coatings, and combinations thereof.

17. The pharmaceutical composition of claim 14, further comprising at least one top coating on the at least one coating comprising the at least one active pharmaceutical ingredient.

18. The pharmaceutical composition of claim 17, wherein the at least one top coating is selected from the group consisting of immediate release coatings, protective coatings, enteric or delayed release coatings, sustained release coatings, barrier coatings, seal coatings, and combinations thereof.

19. The pharmaceutical composition of claim 14, further comprising at least one barrier coating between the capsule and the at least one coating comprising the at least one active pharmaceutical ingredient, and at least one top coating selected from the group consisting of enteric or delayed release coatings, protective coatings, or combinations thereof, on the at least one coating comprising the at least one active pharmaceutical ingredient.

20. The pharmaceutical composition of claim 14, wherein the active pharmaceutical ingredient is selected from the group consisting of analgesics, anti-inflammatory agents, anti-helminthics, anti-arrhythmic agents, anti-asthma agents, anti-bacterial agents, anti-viral agents, anti-coagulants, anti-dementia agents, anti-depressants, anti-diabetics, anti-epileptics, anti-fungal agents, anti-gout agents, anti-hypertensive agents, anti-malarials, anti-migraine agents, anti-muscarinic agents, anti-neoplastic agents, immunosuppressants, anti-protozoal agents, anti-thyroid agents, anti-tussives, anxiolytics, sedatives, hypnotics, neuroleptics, neuroprotective agents, β

-blockers, cardic inotropic agents, cell adhesion inhibitors, corticosteroids, cytokine receptor activity modulators, diuretics, anti-parkinsonian agents, gastrointestinal agents, histamine H-receptor antagonists, keratolytics, lipid regulating agents, muscle relaxants, nitrates and other anti-anginal agents, non-steroid anti-asthma agents, nutritional agents, opioid analgesics, sex hormones, stimulants and anti-erectile dysfunction agents, and combinations thereof.

21. The pharmaceutical composition of claim 20, wherein the active pharmaceutical ingredient is selected from the group consisting of fenofibrate, doxycycline, omeprazole, dutasteride, celecoxib, thalidomide, and salts thereof.

22. The pharmaceutical composition of claim 14, wherein the dosage form is suitable for oral administration.

23. The pharmaceutical composition of claim 14, wherein the capsule is a soft gelatin capsule.

24. The pharmaceutical composition of claim 14, wherein the at least one coating comprising the at least one active pharmaceutical ingredient is applied by spray coating.

25. A method of treating, preventing or reducing the occurrence of a condition in a subject, comprising administering to the subject the pharmaceutical composition of claim 14.

26. The method of claim 25, wherein the condition is selected from the group consisting of:

gastrointestinal conditions, cardiovascular conditions, and pain-related conditions.