ORAL DOSAGE COMBINATION PHARMACEUTICAL PACKAGING

• US 20090087483A1
• Filed: 09/27/2007
• Published: 04/02/2009
• Est. Priority Date: 09/27/2007
• Status: Abandoned Application

• Current Assignee: MicroDose Therapeutx, Inc. (Teva Pharmaceutical Industries Limited)
• Original Assignee: MicroDose Therapeutx, Inc. (Teva Pharmaceutical Industries Limited)
• Inventors: Sison, Raymundo A.
• Application Number:
  US11/863,156
• Publication Number:
  US 20090087483A1
• Time in Patent Office: Days
• US Class Current: 424/451
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084
• CPC Class Codes: A61K 9/4816 Wall or shell material
• 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 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/06 for tuberculosis
• CPC Class Codes: A61P 31/18 for HIV
• CPC Class Codes: A61P 33/06 Antimalarials
• CPC Class Codes: A61P 9/12 Antihypertensives
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Pharmaceutical fixed dose combination products are formed by merging a fixed dose of a first pharmaceutical formulation from primary module, with a fixed dose of a second pharmaceutical formulation from a secondary module. In a preferred embodiment the first and second pharmaceutical formulations are separated from one another in a three piece capsule, a capsule-in-a-capsule or a tablet-in-a-capsule, and the primary and secondary modules are interchangeable.

Claims

1. A pharmaceutical delivery package comprising fixed unit dose quantities of two or more different pharmaceutical formulations (a) combined in a single delivery package, and (b) segregated from one another within said package wherein said package comprises a core capsule containing a first pharmaceutical formulation surrounded at least in part by a half-capsule containing a second pharmaceutical formulation.

2. A pharmaceutical delivery package according to claim 1, wherein the core capsule is formed from gelatin, a starch or a cellulose material.

3. A pharmaceutical delivery package according to claim 2, wherein the cellulose material comprises hydroxypropylmcthylcelluose.

4. A pharmaceutical delivery package according to claim 1, wherein said core capsule and said half capsule are joined together by snap or press fitting.

5. A pharmaceutical delivery package according to claim 1, wherein at least one of the two or more different pharmaceutical formulations is in a powder, pellet or bead form.

6. A pharmaceutical delivery package according to claim 1, wherein at least one of said first and said second pharmaceutical formulations is in a semi-liquid or gel form.

7. A pharmaceutical delivery package according to claim 1, wherein at least one of said first and said second pharmaceutical formulations is in a pre-formed dose form.

8. A pharmaceutical delivery package according to claim 1, wherein the core capsule and the half-capsule are bonded to one another.

9. A pharmaceutical delivery package according to claim 1, wherein the core capsule and the half-capsule are joined together by mating rings, a locking groove and ring, or a locking band.

10. A pharmaceutical delivery package according to claim 1, wherein the core capsule and the half-capsule are joined together by a set-in-place liquid.

11. A pharmaceutical delivery package according to claim 1, wherein the core capsule and/or the half-capsule walls have a physical property selected from thickness, composition, solubility and porosity whereby release of active pharmaceutical formulations contained therein into the alimentary canal may be controlled.

12. A pharmaceutical delivery package according to claim 11, wherein the core capsule and/or the half-capsule walls are acid resistant, and are permeable or soluble in a neutral to alkaline environment.

13. A pharmaceutical delivery package according to claim 1, wherein the core 11 capsule contains a liquid or gel formulation.

14. A pharmaceutical delivery package according to claim 1, wherein one of the pharmaceutical formulations is selected from the group consisting of a vitamin, a dietary supplement, a mineral and a nutraceutical.

15. A pharmaceutical delivery package according to claim 1, comprising combinations of pharmaceutical formulations selected from the group consisting of an anti-diabetic agent and an anti-hypertensive agent;

an anti-diabetic agent and anti-hyperlipidemia agent, wherein the anti-diabetic agent preferably is selected from the group consisting of a sulfonylurea, a meglitinide, a biguanide, an insulin sensitizer and an alpha-glucosidase inhibitor, and the anti-hypertensive agent preferably is selected from the group consisting of an ACE inhibitor, an angiotension II antagonist, a calcium blocker, a beta-blocker and a diuretic, or wherein the anti-diabetic agent preferably is selected from the group consisting of a sulfonylurea, a meglitinide, a biguanide, an insulin sensitizer and an alpha-glucosidase inhibitor, and the anti-hyperlipidemia agent preferably is selected from the group consisting of a statin, a fibrate, a bile acid sequestrant, a cholesterol absorption inhibitor and niacin.

16. A pharmaceutical delivery package according to claim 1, wherein one of the pharmaceutical formulations is selected from an ingredient which mitigates a side effect of the other pharmaceutical formulation;

or which acts as a time control quencher for the other pharmaceutical formulation;

or which facilitates dissolution and/or absorption of the other pharmaceutical formulation, e.g., through pH control;

or, which is fat soluble and the other pharmaceutical formulation contains a fat or oil;

or which contains an enzyme for facilitating absorption and/or bio-availability of the other pharmaceutical formulation, or mitigating side effects of the other pharmaceutical formulation;

or, which includes a surfactant which facilitates absorption or inhibits absorption in a selected part of the alimentary canal;

or which comprises a sleep aid.

17. A pharmaceutical delivery package according to claim 1, wherein the first and the second pharmaceutical formulations are effective for treating the same symptom or disease;

or the first and the second pharmaceutical formulations are both antibiotics;

or one of the pharmaceutical formulations is an anti-viral agent, and the other pharmaceutical formulation is an anti-bacterial agent;

or one of the pharmaceutical formulations is an antibiotic, and the other pharmaceutical formulation is an antibiotic potentiator;

or one of the pharmaceutical formulations comprises an NRTI and the other pharmaceutical formulation comprises an NNRTI;

or one of the pharmaceutical formulations comprises a PPI, and the other pharmaceutical formulation comprises an NNRTI or one of the pharmaceutical formulations comprises an NSAID, and the other pharmaceutical formulation comprises a PPI.

18. A pharmaceutical delivery package according to claim 1, wherein the pharmaceutical formulations comprise agents for treating infectious disease or pain.

19. A pharmaceutical delivery package according to claim 18, wherein the infectious disease comprises HIV/AIDS, TB or malaria.

20. A pharmaceutical delivery package according to claim 1, comprising two or more pharmaceutical formulations selected from the group consisting of Enalapril maleate and analogs and isomers thereof and analogs and isomers of beta adrenergic-blocking agents, methyldopa, nitrate, calcium blocking agents, Hydralazine, Prazosin and Digoxin;

a hypoglycermic agent such as Metformin HCl and analogs and isomers thereof and an angiotensin converting enzyme inhibitor (ACE inhibitor);

a diabetes drug and an angiotensin II receptor antagonist such as Losartan potassium and/or Valsartan;

a diabetes drug and a Beta Adrenergic Blocking Agent such as Bioprolol fumarate or Metoprolol succinate;

a diabetes drug and a Calcium Channel Blocking Agent such as Amlodipine or Nifedipine;

a diabetes drug and a Periferal Adrenergic Blocking Agent such as Prazosin hydrochloride;

a diabetes drug and a Adrenergic central stimulant such as Methyldopa or Clonidine;

a biguanide such as Metformin and a sulfonylurea such as Glipizide;

a biguanide such as Metformin and a thiazolidinedione such as rosiglitazone maleate;

a biguanide such as Metformin and an alpha glucosidase inhibitor such as Cerivastatin;

a short acting oral insulin and a sustained release oral insulin;

a diabetes drug and an ACE Inhibitor combined with a Beta Blocker, a methyldopa nitrate, a calcium channel blocker, Hydralazine, Prazosin, or Digoxin;

a diabetes drug and an ACE Inhibitor and a Beta Blocker;

a diabetes drug and a HMG-CoA reductase inhibitor such as Simvastatin, Atorvastatin, or Pravastatin, and with a bile acid sequestrant such as Colestipol hydrohloride;

a diabetes drug and a HMG-CoA reductase inhibitor and a niacin compound;

a diabetes drug and a HMG-CoA reductase inhibitor or Combination, and with a hypolipidemia agent such as Gemfibrozil;

a pharmaceutical formulation with side effect causing, constipation, nausea, gas/bloating, heartburn, pain or cramp and a second pharmaceutical formulation, mitigating the above side effect of the first formulation, e.g. correspondingly laxative medication, nausea treatment medication, anti-gas and anti-bloating medication, anti-acid medication, pain reliever &

muscle relaxant medication;

a pain medication causing constipation and nausea, oral narcotic and the second formulation containing a stool softener and/or an anti-nausea components;

an anti-cancer drug such as Methotrexate with immediate release, and a “

quencher”

substance, such as L-leukovorin, with delayed release;

a first pharmaceutical formulation and a second pharmaceutical formulation or a substance which optimizes or controls pH such as a buffer for facilitating dissolution, and/or absorption of the first active pharmaceutical formulation;

a first pharmaceutical formulation which is fat soluble and a second pharmaceutical formulation or a substance containing oil;

a first pharmaceutical formulation and an enzyme wherein said enzyme facilitates active pharmaceutical formulation absorption and/or bio-availability or mitigates side effects;

a first pharmaceutical formulation and a nutraceutical or a vitamin, such as Nexium (esomeprazole) and B-group vitamins, and Anti-viral active pharmaceutical formulations and vitamin C or multivitamin supplements;

a pharmaceutical formulation and a surfactant which facilitates absorption or vice versa, inhibits absorption in the certain part of the alimentary canal;

a pharmaceutical formulation and a sleep aid;

a first and second formulation within the same class of pharmaceuticals for treating or preventing the same symptoms or same disease (polypharmacy), such as infectious disease, metabolic disorders, cardiovascular disease, pain, cancer, transplant-related treatment, gastrointestinal disorders, respiratory diseases, autoimmune diseases and vaccines;

an anti-infective active pharmaceutical formulation comprising first and second antibiotics;

an anti-viral and an anti-bacterial pharmaceutical formulation;

a pharmaceutical formulation, for treating cancer and managing symptoms of cancer, for example topoisomerase inhibitor drug, and an anti-cancer monoclonal antibody drug, an antibiotic and an antibiotic potentiator;

a fast release or fast action and slow release or long term action formulations of the same pharmaceutical, such as nitroglycerin, with fast acting/fast dissolving formulation providing for a fast action for acute treatment with a slow release formulation for maintenance;

an antibiotic with fast action/fast dissolution formulation for immediate increase of the concentration in blood plus slow release;

pain medication, with a fast acting formulation for immediate pain relief help combined with a slow release pain maintenance medication;

a sleep aid with a fast dissolving or fast acting formulation for immediate effect combined with a delayed release for maintenance throughout the night, such as Ambien;

two anti-cholesterol pharmaceutical formulations such as statins of different types combined in the combination medication delivery system;

a broad spectrum anti-hypertensive combination comprising two or more hypertension-reducing drugs, including medications of the same type, such as beta-blockers or diuretics, or medications of different types or classes, such as beta-blocker and diuretic;

two or more anti-malaria drugs such as Artesunate and Mefloquine;

Artemether and Lumefantrine;

Chloroquine and Paracetamol; and

at least two of the following;

Artemether;

Lumefantrine;

Artensunate;

Amodiaquine HCl;

Atovaquone-proguanil;

Quinine Sulfate;

Chloroquine Sulfate;

Hydroxychloroquine Sulfate;

Doxycycline;

Mefloquine;

Primaquine;

Sulfadoxine;

Pyrimethamine;

Paracetamol;

at least two nucleoside reverse transcriptase inhibitor (NRTI) medications, including e.g. Abacavir;

lamivudine;

Didanosine;

Emtricitabine;

Stavudine;

Tenofovir, a non-nucleoside reverse transcriptase inhibitor (NNRTI) and a nucleoside reverse transcriptase inhibitor (NRTI) e.g. Nevirapine (NNRTI) and didanozine (NRTI);

Efavirenz (NNRTI) and abacavir sulfate (NRTI);

two NRTI'"'"'s and one NNRTI, e.g. Abacavir and lamivudine and efavirenz or Abacavir and lamivudine and nevirapine;

at least two 2 NRTI'"'"'s and a PPI such as Abacavir and lamivudine and lopinavir/ritonavir;

at least two anti-HIV drug formulations selected from the group consisting of;

abacavir sulfate;

didanozine;

stavudine;

tenofovir;

disoproxil;

fumarate;

zidovudine;

lamivudine;

emtricitabine;

lopinavir/ritonavir;

nevirapine;

efavirenz and nelfinavir;

a combination of AZT and 3TC;

a combination of abacavir and AZT and 3TC;

a combination of lopinavir and ritonavir;

combinations of ABC and 3TC;

a combination of emtricitabine and tenofovir;

at least two of Tuberculosis treatment medications selected from;

Isoniazid;

Rifampicin;

Pyrazinamide;

Ethambutol HCl;

Streptomycin;

Capreomycin;

Cycloserine;

Protionamide;

Macrolides;

Fluoroquinolones; and

p-Salicylic acid;

at least two of the pain treatment medications selected from;

Aspirin;

Carbex;

Codeine;

Luvox;

Marplan;

Nardil;

Neurotin;

OxyContin;

Parnate;

Topamax;

Tylenol/Acetaminophen;

Vicodin;

Xyrem;

Zarontin;

Zoloft and Zomig;

a pH buffering compound and/or an anti-acid compound in combination with aspirin; and

a combination therapy for treatment of lupus nephritis, such as methylprednisolone and cyclophosphamide.

21. A pharmaceutical delivery package as claimed in claim 1 comprising fixed unit dose quantities of two or more different active pharmaceutical formulations (a) combined in a single delivery package, and (b) segregated from one another within said package, characterized by one or more of the following features:

(a) wherein one of the pharmaceutical formulations is selected from the group consisting of a vitamin, a dietary supplement, a mineral and a nutraceutical;

(b) comprising combinations of pharmaceutical formulations selected from the group consisting of an anti-diabetic agent and an anti-hypertensive agent;

an anti-diabetic agent and anti-hyperlipidemia agent, wherein the anti-diabetic agent preferably is selected from the group consisting of a sulfonylurea, a meglitinide, a biguanide, an insulin sensitizer and an alpha-glucosidase inhibitor, and the anti-hypertensive agent preferably is selected from the group consisting of an ACE inhibitor, an angiotension II antagonist, a calcium blocker, a beta-blocker and a diuretic, or wherein the anti-diabetic agent preferably is selected from the group consisting of a sulfonylurea, a meglitinide, a biguanide, an insulin sensitizer and an alpha-glucosidase inhibitor, and the anti-hyperlipidemia agent preferably is selected from the group consisting of a statin, a fibrate, a bile acid sequestrant, a cholesterol absorption inhibitor and niacin;

(c) wherein one of the pharmaceutical formulations is selected from an ingredient which mitigates a side effect of the other pharmaceutical formulation;

or which acts as a time control quencher for the other pharmaceutical formulation;

or which facilitates dissolution and/or absorption of the other pharmaceutical formulation, e.g., through pH control;

or, which is fat soluble and the other pharmaceutical formulation contains a fat or oil;

or which contains an enzyme for facilitating absorption and/or bio-availability of the other pharmaceutical formulation, or mitigating side effects of the other pharmaceutical formulation;

or, which includes a surfactant which facilitates absorption or inhibits absorption in a selected part of the alimentary canal;

or which comprises a sleep aid;

(d) wherein the first and the second pharmaceutical formulations are effective for treating the same symptom or disease;

or the first and the second pharmaceutical formulations are both antibiotics;

or one of the pharmaceutical formulations is an anti-viral agent, and the other pharmaceutical formulation is an anti-bacterial agent;

or one of the pharmaceutical formulations is an antibiotic, and the other pharmaceutical formulation is an antibiotic potentiator;

or one of the pharmaceutical formulations comprises an NRTI and the other pharmaceutical formulation comprises an NNRTI;

or one of the pharmaceutical formulations comprises a PPI, and the other pharmaceutical formulation comprises an NNRTI or one of the pharmaceutical formulations comprises an NSAID, and the other pharmaceutical formulation comprises a PPI;

(e) wherein the pharmaceutical formulations comprise agents for treating infectious disease or pain;

(f) wherein the infectious disease comprises HIV/AIDS, TB or malaria; and

(g) comprising two or more pharmaceutical formulations selected from the group consisting of Enalapril maleate and analogs and isomers thereof and analogs and isomers of beta adrenergic-blocking agents, methyldopa, nitrate, calcium blocking agents, Hydralazine, Prazosin and Digoxin;

a hypoglycermic agent such as Metformin HCl and analogs and isomers thereof and an angiotensin converting enzyme inhibitor (ACE inhibitor);

a diabetes drug and an angiotensin II receptor antagonist such as Losartan potassium and/or Valsartan;

a diabetes drug and a Beta Adrenergic Blocking Agent such as Bioprolol fumarate or Metoprolol succinate;

a diabetes drug and a Calcium Channel Blocking Agent such as Amlodipine or Nifedipine;

a diabetes drug and a Periferal Adrenergic Blocking Agent such as Prazosin hydrochloride;

a diabetes drug and a Adrenergic central stimulant such as Methyldopa or Clonidine;

a biguanide such as Metformin and a sulfonylurea such as Glipizide;

a biguanide such as Metformin and a thiazolidinedione such as rosiglitazone maleate;

a biguanide such as Metfornin and an alpha glucosidase inhibitor such as Cerivastatin;

a short acting oral insulin and a sustained release oral insulin;

a diabetes drug and an ACE Inhibitor combined with a Beta Blocker, a methyldopa nitrate, a calcium channel blocker, Hydralazine, Prazosin, or Digoxin;

a diabetes drug and an ACE Inhibitor and a Beta Blocker;

a diabetes drug and a HMG-CoA reductase inhibitor such as Simvastatin, Atorvastatin, or Pravastatin, and with a bile acid sequestrant such as Colestipol hydrohloride;

a diabetes drug and a HMG-CoA reductase inhibitor and a niacin compound;

a diabetes drug and a HMG-CoA reductase inhibitor or Combination, and with a hypolipidemia agent such as Gemfibrozil;

a pharmaceutical formulation with side effect causing, constipation, nausea, gas/bloating, heartburn, pain or cramp and a second pharmaceutical formulation, mitigating the above side effect of the first ingredient, e.g. correspondingly laxative medication, nausea treatment medication, anti-gas and anti-bloating medication, anti-acid medication, pain reliever &

muscle relaxant medication;

a pain medication causing constipation and nausea, oral narcotic and the second formulation containing a stool softener and/or an anti-nausea components;

an anti-cancer drug such as Methotrexate with immediate release, and a “

quencher”

substance, such as L-leukovorin, with delayed release;

a first pharmaceutical formulation and a second pharmaceutical formulation or a substance which optimizes or controls pH such as a buffer for facilitating dissolution, and/or absorption of the first active pharmaceutical formulation;

a first pharmaceutical formulation which is fat soluble and a second pharmaceutical formulation or a substance containing oil;

a first pharmaceutical formulation and an enzyme wherein said enzyme facilitates active pharmaceutical formulation absorption and/or bio-availability or mitigates side effects;

a first pharmaceutical formulation and a nutraceutical or a vitamin, such as Nexium (esomeprazole) and B-group vitamins, and Anti-viral active pharmaceutical formulations and vitamin C or multivitamin supplements;

a pharmaceutical formulation and a surfactant which facilitates absorption or vice versa, inhibits absorption in the certain part of the alimentary canal;

a pharmaceutical formulation and a sleep aid;

a first and second formulation within the same class of pharmaceuticals for treating or preventing the same symptoms or same disease (polypharmacy), such as infectious disease, metabolic disorders, cardiovascular disease, pain, cancer, transplant-related treatment, gastrointestinal disorders, respiratory diseases, autoimmune diseases and vaccines;

anti-infective active pharmaceutical formulation comprising first and second antibiotics;

an anti-viral and an anti-bacterial pharmaceutical formulation;

a pharmaceutical formulation, for treating cancer and managing symptoms of cancer, for example topoisomerase inhibitor drug, and an anti-cancer monoclonal antibody drug, an antibiotic and an antibiotic potentiator;

a fast release or fast action and slow release or long term action formulations of the same pharmaceutical, such as nitroglycerin, with fast acting/fast dissolving formulation providing for a fast action for acute treatment with a slow release formulation for maintenance;

antibiotic with fast action/fast dissolution formulation for immediate increase of the concentration in blood plus slow release;

pain medication, with a fast acting formulation for immediate pain relief help combined with a slow release pain maintenance medication;

sleep aid with a fast dissolving or fast acting formulation for immediate effect combined with a delayed release for maintenance throughout the night, such as Ambien;

two anti-cholesterol pharmaceutical formulations such as statins of different types combined in the combination medication delivery system;

a broad spectrum anti-hypertensive combination comprising two or more hypertension-reducing drugs, including medications of the same type, such as beta-blockers or diuretics, or medications of different types or classes, such as beta-blocker and diuretic;

two or more anti-malaria drugs such as Artesunate and Mefloquine;

Artemether and Lumefantrine;

Chloroquine and Paracetamol; and

at least two of the following;

Artemether;

Lumefantrine;

Artensunate;

Amodiaquine HCl;

Atovaquone-proguanil;

Quinine Sulfate;

Chloroquine Sulfate;

Hydroxychloroquine Sulfate;

Doxycycline;

Mefloquine;

Primaquine;

Sulfadoxine;

Pyrimethamine;

Paracetamol;

at least two nucleoside reverse transcriptase inhibitor (NRTI) medications, including e.g. Abacavir;

lamivudine;

Didanosine;

Emtricitabine;

Stavudine;

Tenofovir, a non-nucleoside reverse transcriptase inhibitor (NNRTI) and a nucleoside reverse transcriptase inhibitor (NRTI) e.g. Nevirapine (NNRTI) and didanozine (NRTI);

Efavirenz (NNRTI) and abacavir sulfate (NRTI);

two NRTI'"'"'s and one NNRTI, e.g. Abacavir and lamivudine and efavirenz or Abacavir and lamivudine and nevirapine;

at least two 2 NRTI'"'"'s and a PPI such as Abacavir and lamivudine and lopinavir/ritonavir;

at least two anti-HIV drug formulations selected from the group consisting of;

abacavir sulfate;

didanozine;

stavudine;

tenofovir;

disoproxil;

fumarate;

zidovudine;

lamivudine;

emtricitabine;

lopinavir/ritonavir;

nevirapine;

efavirenz and nelfinavir;

a combination of AZT and 3TC;

a combination of abacavir and AZT and 3TC;

a combination of lopinavir and ritonavir;

combinations of ABC and 3TC;

a combination of emtricitabine and tenofovir;

at least two of Tuberculosis treatment medications selected from;

Isoniazid;

Rifampicin;

Pyrazinamide;

Ethambutol HCl;

Streptomycin;

Capreomycin;

Cycloserine;

Protionamide;

Macrolides;

Fluoroquinolones; and

p-Salicylic acid;

at least two of the pain treatment medications selected from;

Aspirin;

Carbex;

Codeine;

Luvox;

Marplan;

Nardil;

Neurotin;

OxyContin;

Parnate;

Topamax;

Tylenol/Acetaminophen;

Vicodin;

Xyrem;

Zarontin;

Zoloft and Zomig;

a pH buffering compound and/or an anti-acid compound in combination with aspirin; and

a combination therapy for treatment of lupus nephritis, such as methylprednisolone and cyclophosphamide.

23. A pharmaceutical delivery package as claimed in claim 1, comprising fixed unit dose quantities of two or more different pharmaceutical formulations (a) combined in a single delivery package, and (b) segregated from one another within said package, formed by the process of claim 22.

22. A process for packaging of two or more different pharmaceutical formulations in a single delivery package, comprising providing a dose of a first pharmaceutical formulation, in a primary process module, and combining the dose of the first pharmaceutical formulation with a dose of a second pharmaceutical formulation from a secondary process module.

24. A modular pharmaceutical delivery package comprising a tablet-in-a-capsule, formed by the process of claim 22.

25. A modular pharmaceutical delivery package comprising a three piece capsule or a capsule-in-a-capsule, formed by the process of claim 22.

26. The process of claim 25, wherein the primary process module comprises a pharmaceutical formulation encapsulated in a two-piece capsule, and the secondary process module comprises a second pharmaceutical formulation loaded in a half-capsule and merged with the primary process module.

27. The process of claim 25, wherein the first pharmaceutical ingredient is formed as a segregated tablet or capsule which is then loaded, together with the second pharmaceutical formulation, in a capsule.

28. The process of claim 26, wherein the first pharmaceutical formulation is encapsulated or delivered from bulk to said two-piece capsule, and the second pharmaceutical formulation is delivered from bulk to said second half capsule which is joined to the two-piece capsule.

29. The process of claim 25, wherein the first and/or the second pharmaceutical formulations are prepared in separate process streams.

30. The process of claim 29, wherein at least one of the process streams includes one or more of the steps of mixing, blending, screening, granulating, wetting and drying, milling, coating and/or compressing.

31. A process for packaging two or more different pharmaceutical formulations in a single delivery package, comprising encapsulating a unit dose quantity of said first pharmaceutical formulation in a capsule, loading a dose quantity of a second pharmaceutical formulation in a half capsule, and, joining the half capsule to the capsule.

32. A process for packaging two or more different pharmaceutical formulations in a single delivery package, comprising providing a first dose quantity of a first pharmaceutical formulation, encapsulated in a first capsule, and supplying a dose quantity of a second pharmaceutical formulation in a second capsule, and joining the first capsule to the second capsule.

33. A process for manufacturing a pharmaceutical delivery package comprising unit dose quantities of two or more different pharmaceutical formulations combined in a single delivery package which comprises providing said two or more pharmaceutical formulations in separate process modules;

loading one of the pharmaceutical formulations in an isolated compartment in a capsule;

adding the second pharmaceutical formulation to the capsule; and

sealing the capsule to create a single delivery package

34. The process as claimed in claim 33, wherein the capsule comprises a three-piece capsule.

35. The process as claimed in claim 34, wherein a two-piece capsule is filled in a first process module, and the filled two-piece capsule is merged with a half capsule, a second capsule or a tablet filled in a second process module.

36. The process as claimed in claim 33, including the step of separating the two or more pharmaceutical formulations by a physical barrier.

37. The process as claimed in claim 33, wherein the process modules are interchangeable.