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Details for Patent: 8,236,352

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Details for Patent: 8,236,352

Title:Glipizide compositions
Abstract: The present invention is directed to nanoparticulate compositions comprising glipizide. The glipizide particles of the composition preferably have an effective average particle size of less than about 2 microns.
Inventor(s): Bosch; H. William (Bryn Mawr, PA), Ryde; Niels P. (Malvern, PA), Jain; Rajeev A. (Farmingham, MA), Swanson; Jon (North Wales, PA), Hontz; Robert (Newtown Square, PA), Devane; John G. (Athlone, IE), Cumming; Kenneth Ian (Essex, GB), Clancy; Maurice Joseph Anthony (Celbridge, IE), Codd; Janet Elizabeth (Wexford, IE), Liversidge; Gary G. (Westchester, PA)
Assignee: Alkermes Pharma Ireland Limited (Dublin, IE)
Filing Date:Nov 05, 2003
Application Number:10/701,064
Claims:1. A composition comprising: (a) nanoparticles of spray-dried glipizide or a salt thereof, wherein the glipizide nanoparticles have an effective average particle size of less than 2000 nm; and (b) at least one surface stabilizer adsorbed on the surface of the glipizide nanoparticles; wherein: (i) the surface stabilizer is free of intermolecular cross-linkages; (ii) the glipizide nanoparticles or a salt thereof is present in an amount of from about 99.5% to about 0.001%, by weight, based on the total combined weight of the glipizide nanoparticles or a salt thereof and at least one surface stabilizer, not including other excipients; (iii) the at least one surface stabilizer is present in an amount of from about 0.5% to about 99.999% by weight, based on the total combined dry weight of the glipizide nanoparticles or a salt thereof and at least one surface stabilizer, not including other excipients; (iv) upon administration to a mammal, the glipizide nanoparticles redisperse such that the nanoparticles have an effective average particle size of less than 2 microns; and (v) the composition exhibits a C.sub.max which is at least 50% greater than the C.sub.max exhibited by a non-nanoparticulate glipizide composition when administered at the same dosage.

2. The composition of claim 1, wherein the glipizide is selected from the group consisting of a crystalline phase, an amorphous phase, and a semi-crystalline phase.

3. The composition of claim 1, wherein the effective average particle size of the spray-dried glipizide nanoparticles is selected from the group consisting of less than 1900 nm, less than 1800 nm, less than 1700 nm, less than 1600 nm, less than 1500 nm, less than 1400 nm, less than 1300 nm, less than 1200 nm, less than 1100 nm, less than 1000 nm, less than 900 nm, less than 800 nm, less than 700 nm, less than 600 nm, less than 500 nm, less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 100 nm, less than 75 nm, and less than 50 nm.

4. The composition of claim 1, wherein the composition is formulated for administration selected from the group consisting of oral, pulmonary, rectal, ophthalmic, colonic, parenteral, intracisternal, intravaginal, intraperitoneal, local, buccal, nasal, and topical administration.

5. The composition of claim 1 formulated into a dosage form selected from the group consisting of liquid dispersions, oral suspensions, gels, aerosols, ointments, creams, controlled release formulations, fast melt formulations, lyophilized formulations, tablets, capsules, delayed release formulations, extended release formulations, pulsatile release formulations, and mixed immediate release and controlled release formulations.

6. The composition of claim 1, wherein the composition further comprises one or more pharmaceutically acceptable excipients, carriers, or a combination thereof.

7. The composition of claim 1, comprising at least two surface stabilizers.

8. The composition of claim 1, wherein the surface stabilizer is selected from the group consisting of an anionic surface stabilizer, a cationic surface stabilizer, a zwitterionic surface stabilizer, and an ionic surface stabilizer.

9. The composition of claim 8, wherein the at least one surface stabilizer is selected from the group consisting of cetyl pyridinium chloride, gelatin, casein, phosphatides, dextran, glycerol, gum acacia, cholesterol, tragacanth, stearic acid, benzalkonium chloride, calcium stearate, glycerol monostearate, cetostearyl alcohol, cetomacrogol emulsifying wax, sorbitan esters, polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyethylene glycols, dodecyl trimethyl ammonium bromide, polyoxyethylene stearates, colloidal silicon dioxide, phosphates, sodium dodecylsulfate, carboxymethylcellulose calcium, hydroxypropyl celluloses, hypromellose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylcellulose, hypromellose phthalate, noncrystalline cellulose, magnesium aluminum silicate, triethanolamine, polyvinyl alcohol, polyvinylpyrrolidone, 4-(1,1,3,3-tetramethylbutyl)-phenol polymer with ethylene oxide and formaldehyde, poloxamers; poloxamines, a charged phospholipid, dioctylsulfosuccinate, dialkylesters of sodium sulfosuccinic acid, sodium lauryl sulfate, alkyl aryl polyether sulfonates, mixtures of sucrose stearate and sucrose distearate, p-isononylphenoxypoly-(glycidol), decanoyl-N-methylglucamide; n-decyl-D-glucopyranoside; n-decyl-D-maltopyranoside; n-dodecyl-D-glucopyranoside; n-dodecyl-D-maltoside; heptanoyl-N-methylglucamide; n-heptyl-D-glucopyranoside; n-heptyl-D-thioglucoside; n-hexyl-D-glucopyranoside; nonanoyl-N-methylglucamide; n-noyl-D-glucopyranoside; octanoyl-N-methylglucamide; n-octyl-D-glucopyranoside; octyl-D-thioglucopyranoside; lysozyme, PEG-phospholipid, PEG-cholesterol, PEG-cholesterol derivative, PEG-vitamin A, and random copolymers of vinyl acetate and vinyl pyrrolidone.

10. The composition of claim 8, wherein the at least one cationic surface stabilizer is selected from the group consisting of a polymer, a biopolymer, a polysaccharide, a cellulosic, an alginate, a nonpolymeric compound, and a phospholipid.

11. The composition of claim 8, wherein the surface stabilizer is selected from the group consisting of cationic lipids, polymethylmethacrylate trimethylammonium bromide, sulfonium compounds, polyvinylpyrrolidone-2-dimethylaminoethyl methacrylate dimethyl sulfate, hexadecyltrimethyl ammonium bromide, phosphonium compounds, quarternary ammonium compounds, benzyl-di(2-chloroethyl)ethylammonium bromide, coconut trimethyl ammonium chloride, coconut trimethyl ammonium bromide, coconut methyl dihydroxyethyl ammonium chloride, coconut methyl dihydroxyethyl ammonium bromide, decyl triethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride bromide, C.sub.12-15dimethyl hydroxyethyl ammonium chloride, C.sub.12-15dimethyl hydroxyethyl ammonium chloride bromide, coconut dimethyl hydroxyethyl ammonium chloride, coconut dimethyl hydroxyethyl ammonium bromide, myristyl trimethyl ammonium methyl sulphate, lauryl dimethyl benzyl ammonium chloride, lauryl dimethyl benzyl ammonium bromide, lauryl dimethyl (ethenoxy).sub.4 ammonium chloride, lauryl dimethyl (ethenoxy).sub.4 ammonium bromide, N-alkyl (C.sub.12-18)dimethylbenzyl ammonium chloride, N-alkyl (C.sub.14-18)dimethyl-benzyl ammonium chloride, N-tetradecylidmethylbenzyl ammonium chloride monohydrate, dimethyl didecyl ammonium chloride, N-alkyl and (C.sub.12-14) dimethyl 1-napthylmethyl ammonium chloride, trimethylammonium halide, alkyl-trimethylammonium salts, dialkyl-dimethylammonium salts, lauryl trimethyl ammonium chloride, ethoxylated alkyamidoalkyldialkylammonium salt, an ethoxylated trialkyl ammonium salt, dialkylbenzene dialkylammonium chloride, N-didecyldimethyl ammonium chloride, N-tetradecyldimethylbenzyl ammonium, chloride monohydrate, N-alkyl(C.sub.12-14) dimethyl 1-naphthylmethyl ammonium chloride, dodecyldimethylbenzyl ammonium chloride, dialkyl benzenealkyl ammonium chloride, lauryl trimethyl ammonium chloride, alkylbenzyl methyl ammonium chloride, alkyl benzyl dimethyl ammonium bromide, C.sub.12 trimethyl ammonium bromides, C.sub.15 trimethyl ammonium bromides, C.sub.17 trimethyl ammonium bromides, dodecylbenzyl triethyl ammonium chloride, poly-diallyldimethylammonium chloride dimethyl ammonium chlorides, alkyldimethylammonium halogenides, tricetyl methyl ammonium chloride, decyltrimethylammonium bromide, dodecyltriethylammonium bromide, tetradecyltrimethylammonium bromide, methyl trioctylammonium chloride, tetrabutylammonium bromide, benzyl trimethylammonium bromide, choline esters, benzalkonium chloride, stearalkonium chloride compounds, cetyl pyridinium bromide, cetyl pyridinium chloride, halide salts of quaternized polyoxyethylalkylamines, alkyl pyridinium salts; amines, amine salts, amine oxides, imide azolinium salts, protonated quaternary acrylamides, methylated quaternary polymers, and cationic guar.

12. The composition of any of claim 8, 10, or 11, wherein the composition is bioadhesive.

13. The composition of claim 1, comprising as a surface stabilizer hydroxypropyl cellulose.

14. The composition of claim 1 further comprising at least one additional glipizide composition having an effective average particle size which is different from the effective average particle size of the spray-dried glipizide nanoparticles of (a).

15. The composition of claim 1, additionally comprising one or more non-glipizide active agents.

16. The composition of claim 15, wherein said additional one or more non-glipizide active agents are selected from the group consisting of nutraceuticals, amino acids, proteins, peptides, nucleotides, anti-obesity drugs, central nervous system stimulants, carotenoids, corticosteroids, elastase inhibitors, anti-fungals, oncology therapies, anti-emetics, analgesics, cardiovascular agents, anti-inflammatory agents, anthelmintics, anti-arrhythmic agents, antibiotics, anticoagulants, antidepressants, antidiabetic agents, antiepileptics, antihistamines, antihypertensive agents, antimuscarinic agents, antimycobacterial agents, antineoplastic agents, immunosuppressants, antithyroid agents, antiviral agents, anxiolytics, sedatives, astringents, alpha-adrenergic receptor blocking agents, beta-adrenoceptor blocking agents, blood products, blood substitutes, cardiac inotropic agents, contrast media, corticosteroids, cough suppressants, diagnostic agents, diagnostic imaging agents, diuretics, dopaminergics, haemostatics, immunological agents, lipid regulating agents, muscle relaxants, parasympathomimetics, parathyroid calcitonin, parathyroid biphosphonates, prostaglandins, radio-pharmaceuticals, sex hormones, anti-allergic agents, stimulants, anoretics, sympathomimetics, thyroid agents, vasodilators, and xanthines.

17. The composition of claim 15, wherein said additional one or more non-glipizide active agents are selected from the group consisting of acyclovir, alprazolam, altretamine, amiloride, amiodarone, benztropine mesylate, bupropion, cabergoline, candesartan, cerivastatin, chlorpromazine, ciprofloxacin, cisapride, clarithromycin, clonidine, clopidogrel, cyclobenzaprine, cyproheptadine, delavirdine, desmopressin, diltiazem, dipyridamole, dolasetron, enalapril maleate, enalaprilat, famotidine, felodipine, furazolidone, glipizide, irbesartan, ketoconazole, lansoprazole, loratadine, loxapine, mebendazole, mercaptopurine, milrinone lactate, minocycline, mitoxantrone, nelfinavir mesylate, nimodipine, norfloxacin, olanzapine, omeprazole, penciclovir, pimozide, tacolimus, quazepam, raloxifene, rifabutin, rifampin, risperidone, rizatriptan, saquinavir, sertraline, sildenafil, acetyl-sulfisoxazole, temazepam, thiabendazole, thioguanine, trandolapril, triamterene, trimetrexate, troglitazone, trovafloxacin, verapamil, vinblastine sulfate, mycophenolate, atovaquone, atovaquone, proguanil, ceftazidime, cefuroxime, etoposide, terbinafine, thalidomide, fluconazole, amsacrine, dacarbazine, teniposide, and acetylsalicylate.

18. The composition of claim 1, wherein upon administration the composition redisperses such that the spray-dried glipizide nanoparticles have an effective average particle size selected from the group consisting of less than 1900 nm, less than 1800 nm, less than 1700 nm, less than 1600 nm, less than 1500 nm, less than 1400 nm, less than 1300 nm, less than 1200 nm, less than 1100 nm, less than 1000 nm, less than 900 nm, less than 800 nm, less than 700 nm, less than 600 nm, less than 500 nm, less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 150 nm, less than 100 nm, less than 75 nm, and less than 50 nm.

19. The composition of claim 1, wherein the composition redisperses in a biorelevant media such that the spray-dried nanoparticles have an effective average particle size of less than 2 microns.

20. The composition of claim 19, wherein the biorelevant media is selected from the group consisting of water, aqueous electrolyte solutions, aqueous solutions of a salt, aqueous solutions of an acid, aqueous solutions of a base, and combinations thereof.

21. The composition of claim 19, wherein the composition redisperses in a biorelevant media such that the spray-dried glipizide nanoparticles have an effective average particle size selected from the group consisting of less than 1900 nm, less than 1800 nm, less than 1700 nm, less than 1600 nm, less than 1500 nm, less than 1400 nm, less than 1300 nm, less than 1200 nm, less than 1100 nm, less than 1000 nm, less than 900 nm, less than 800 nm, less than 700 nm, less than 600 nm, less than 500 nm, less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 150 nm, less than 100 nm, less than 75 nm, and less than 50 nm.

22. The composition of claim 1 formulated into a liquid dosage form, wherein the dosage form has a viscosity of less than 2000 mPas, measured at 20.degree. C., at a shear rate of 0.1 (1/s).

23. The composition of claim 22, having a viscosity at a shear rate of 0.1 (1/s), measured at 20.degree. C., selected from the group consisting of from about 2000 mPas to about 1 mPas, from about 1900 mPas to about 1 mPas, from about 1800 mPas to about 1 mPas, from about 1700 mPas to about 1 mPas, from about 1600 mPas to about 1 mPas, from about 1500 mPas to about 1 mPas, from about 1400 mPas to about 1 mPas, from about 1300 mPas to about 1 mPas, from about 1200 mPas to about 1 mPas, from about 1100 mPas to about 1 mPas, from about 1000 mPas to about 1 mPas, from about 900 mPas to about 1 mPas, from about 800 mPas to about 1 mPas, from about 700 mPas to about 1 mPas, from about 600 mPas to about 1 mPas, from about 500 mPas to about 1 mPas, from about 400 mPas to about 1 mPas, from about 300 mPas to about 1 mPas, from about 200 mPas to about 1 mPas, from about 175 mPas to about 1 mPas, from about 150 mPas to about 1 mPas, from about 125 mPas to about 1 mPas, from about 100 mPas to about 1 mPas, from about 75 mPas to about 1 mPas, from about 50 mPas to about 1 mPas, from about 25 mPas to about 1 mPas, from about 15 mPas to about 1 mPas, from about 10 mPas to about 1 mPas, and from about 5 mPas to about 1 mPas.

24. The composition of claim 22, wherein the viscosity of the dosage form is selected from the group consisting of less than 1/200, less than 1/100, less than 1/50, less than 1/25, and less than 1/10 of the viscosity of a liquid dosage form of a non-nanoparticulate composition of glipizide, at about the same concentration per ml of glipizide.

25. The composition of claim 22, wherein the viscosity of the dosage form is selected from the group consisting of less than 5%, less than 10%, less than 15%, less than 20%, less than 25%, less than 30%, less than 35%, less than 40%, less than 45%, less than 50%, less than 55%, less than 60%, less than 65%, less than 70%, less than 75%, less than 80%, less than 85%, and less than 90% of the viscosity of a liquid dosage form of a non-nanoparticulate composition of the glipizide, at about the same concentration per ml of glipizide.

26. A method of treating diabetes in a subject in need thereof comprising administering to the subject an effective amount of a composition comprising: (a) nanoparticles of a spray-dried glipizide or a salt thereof, wherein the glipizide nanoparticles have an effective average particle size of less than 2000 nm; and (b) at least one surface stabilizer adsorbed on the surface of the glipizide nanoparticles, wherein: (i) the surface stabilizer is free of intermolecular cross-linkages; (ii) the nanoparticle glipizide or a salt thereof is present in an amount of from about 99.5% to about 0.001%, by weight, based on the total combined weight of the nanoparticle glipizide or a salt thereof and at least one surface stabilizer, not including other excipients; (iii) the at least one surface stabilizer is present in an amount of from about 0.5% to about 99.999% by weight, based on the total combined dry weight of the nanoparticle glipizide or a salt thereof and at least one surface stabilizer, not including other excipients; (iv) upon administration to a mammal, the glipizide nanoparticles redisperse such that the nanoparticles have an effective average particle size of less than 2 microns; and (v) the composition exhibits a C.sub.max which is at least 50% greater than the C.sub.max exhibited by a non-nanoparticulate glipizide composition when administered at the same dosage.

27. The method of claim 26, wherein the glipizide or a salt thereof is selected from the group consisting of a crystalline phase, an amorphous phase, and a semi-crystalline phase.

28. The method of claim 26, wherein the effective average particle size of the spray-dried glipizide nanoparticles is selected from the group consisting of less than 1900 nm, less than 1800 nm, less than 1700 nm, less than 1600 nm, less than 1500 nm, less than 1400 nm, less than 1300 nm, less than 1200 nm, less than 1100 nm, less than 1000 nm, less than 900 nm, less than 800 nm, less than 700 nm, less than 600 nm, less than 500 nm, less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 100 nm, less than 75 nm, and less than 50 nm.

29. The method of claim 26, wherein the composition is formulated for administration selected from the group consisting of oral, pulmonary, rectal, ophthalmic, colonic, parenteral, intracisternal, intravaginal, intraperitoneal, local, buccal, nasal, and topical administration.

30. The method of claim 26, wherein the composition is a dosage form selected from the group consisting of liquid dispersions, oral suspensions, gels, aerosols, ointments, creams, controlled release formulations, fast melt formulations, lyophilized formulations, tablets, capsules, delayed release formulations, extended release formulations, pulsatile release formulations, and mixed immediate release and controlled release formulations.

31. The method of claim 26, wherein the composition further comprises one or more pharmaceutically acceptable excipients, carriers, or a combination thereof.

32. The method of claim 26, utilizing at least two surface stabilizers.

33. The method of claim 26, wherein the surface stabilizer is selected from the group consisting of an anionic surface stabilizer, a cationic surface stabilizer, a zwitterionic surface stabilizer, and an ionic surface stabilizer.

34. The method of claim 33, wherein the at least one surface stabilizer is selected from the group consisting of cetyl pyridinium chloride, gelatin, casein, phosphatides, dextran, glycerol, gum acacia, cholesterol, tragacanth, stearic acid, benzalkonium chloride, calcium stearate, glycerol monostearate, cetostearyl alcohol, cetomacrogol emulsifying wax, sorbitan esters, polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyethylene glycols, dodecyl trimethyl ammonium bromide, polyoxyethylene stearates, colloidal silicon dioxide, phosphates, sodium dodecylsulfate, carboxymethylcellulose calcium, hydroxypropyl celluloses, hypromellose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylcellulose, hypromellose phthalate, noncrystalline cellulose, magnesium aluminum silicate, triethanolamine, polyvinyl alcohol, polyvinylpyrrolidone, 4-(1,1,3,3-tetramethylbutyl)-phenol polymer with ethylene oxide and formaldehyde, poloxamers; poloxamines, a charged phospholipid, dioctylsulfosuccinate, dialkylesters of sodium sulfosuccinic acid, sodium lauryl sulfate, alkyl aryl polyether sulfonates, mixtures of sucrose stearate and sucrose distearate, p-isononylphenoxypoly-(glycidol), decanoyl-N-methylglucamide; n-decyl-D-glucopyranoside; n-decyl-D-maltopyranoside; n-dodecyl-D-glucopyranoside; n-dodecyl-D-maltoside; heptanoyl-N-methylglucamide; n-heptyl-D-glucopyranoside; n-heptyl-D-thioglucoside; n-hexyl-D-glucopyranoside; nonanoyl-N-methylglucamide; n-noyl-D-glucopyranoside; octanoyl-N-methylglucamide; n-octyl-D-glucopyranoside; octyl-D-thioglucopyranoside; lysozyme, PEG-phospholipid, PEG-cholesterol, PEG-cholesterol derivative, PEG-vitamin A, PEG-vitamin E, and random copolymers of vinyl acetate and vinyl pyrrolidone.

35. The method of claim 33, wherein the at least one cationic surface stabilizer is selected from the group consisting of a polymer, a biopolymer, a polysaccharide, a cellulosic, an alginate, a nonpolymeric compound, and a phospholipid.

36. The method of claim 33, wherein the surface stabilizer is selected from the group consisting of benzalkonium chloride, polymethylmethacrylate trimethylammonium bromide, polyvinylpyrrolidone-2-dimethylaminoethyl methacrylate dimethyl sulfate, hexadecyltrimethyl ammonium bromide, cationic lipids, sulfonium compounds, phosphonium compounds, quarternary ammonium compounds, benzyl-di(2-chloroethyl)ethylammonium bromide, coconut trimethyl ammonium chloride, coconut trimethyl ammonium bromide, coconut methyl dihydroxyethyl ammonium chloride, coconut methyl dihydroxyethyl ammonium bromide, decyl triethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride bromide, C.sub.12-15dimethyl hydroxyethyl ammonium chloride, C.sub.12-15dimethyl hydroxyethyl ammonium chloride bromide, coconut dimethyl hydroxyethyl ammonium chloride, coconut dimethyl hydroxyethyl ammonium bromide, myristyl trimethyl ammonium methyl sulphate, lauryl dimethyl benzyl ammonium chloride, lauryl dimethyl benzyl ammonium bromide, lauryl dimethyl (ethenoxy).sub.4 ammonium chloride, lauryl dimethyl (ethenoxy).sub.4 ammonium bromide, N-alkyl (C.sub.12-18)dimethylbenzyl ammonium chloride, N-alkyl (C.sub.14-18)dimethyl-benzyl ammonium chloride, N-tetradecylidmethylbenzyl ammonium chloride monohydrate, dimethyl didecyl ammonium chloride, N-alkyl and (C.sub.12-14) dimethyl 1-napthylmethyl ammonium chloride, trimethylammonium halide, alkyl-trimethylammonium salts, dialkyl-dimethylammonium salts, lauryl trimethyl ammonium chloride, ethoxylated alkyamidoalkyldialkylammonium salt, an ethoxylated trialkyl ammonium salt, dialkylbenzene dialkylammonium chloride, N-didecyldimethyl ammonium chloride, N-tetradecyldimethylbenzyl ammonium, chloride monohydrate, N-alkyl(C.sub.12-14) dimethyl 1-naphthylmethyl ammonium chloride, dodecyldimethylbenzyl ammonium chloride, dialkyl benzenealkyl ammonium chloride, lauryl trimethyl ammonium chloride, alkylbenzyl methyl ammonium chloride, alkyl benzyl dimethyl ammonium bromide, C.sub.12 trimethyl ammonium bromides, C.sub.15 trimethyl ammonium bromides, C.sub.17 trimethyl ammonium bromides, dodecylbenzyl triethyl ammonium chloride, poly-diallyldimethylammonium chloride dimethyl ammonium chlorides, alkyldimethylammonium halogenides, tricetyl methyl ammonium chloride, decyltrimethylammonium bromide, dodecyltriethylammonium bromide, tetradecyltrimethylammonium bromide, methyl trioctylammonium chloride, tetrabutylammonium bromide, benzyl trimethylammonium bromide, choline esters, benzalkonium chloride, stearalkonium chloride compounds, cetyl pyridinium bromide, cetyl pyridinium chloride, halide salts of quaternized polyoxyethylalkylamines, alkyl pyridinium salts; amines, amine salts, amine oxides, imide azolinium salts, protonated quaternary acrylamides, methylated quaternary polymers, and cationic guar.

37. The method of any of claim 33, 35, or 36, wherein the composition is bioadhesive.

38. The method of claim 26, utilizing hydroxypropylcellulose as a surface stabilizer.

39. The method of claim 26, additionally comprising administering one or more non-glipizide active agents.

40. The method of claim 39, wherein said additional one or more non-glipizide active agents are selected from the group consisting of nutraceuticals, amino acids, proteins, peptides, nucleotides, anti-obesity drugs, central nervous system stimulants, carotenoids, corticosteroids, elastase inhibitors, anti-fungals, oncology therapies, anti-emetics, analgesics, cardiovascular agents, anti-inflammatory agents, anthelmintics, anti-arrhythmic agents, antibiotics, anticoagulants, antidepressants, antidiabetic agents, antiepileptics, antihistamines, antihypertensive agents, antimuscarinic agents, antimycobacterial agents, antineoplastic agents, immunosuppressants, antithyroid agents, antiviral agents, anxiolytics, sedatives, astringents, alpha-adrenergic receptor blocking agents, beta-adrenoceptor blocking agents, blood products, blood substitutes, cardiac inotropic agents, contrast media, corticosteroids, cough suppressants, diagnostic agents, diagnostic imaging agents, diuretics, dopaminergics, haemostatics, immunological agents, lipid regulating agents, muscle relaxants, parasympathomimetics, parathyroid calcitonin, parathyroid biphosphonates, prostaglandins, radio-pharmaceuticals, sex hormones, anti-allergic agents, stimulants, anoretics, sympathomimetics, thyroid agents, vasodilators, and xanthines.

41. The method of claim 39, wherein said additional one or more non-glipizide active agents are selected from the group consisting of acyclovir, alprazolam, altretamine, amiloride, amiodarone, benztropine mesylate, bupropion, cabergoline, candesartan, cerivastatin, chlorpromazine, ciprofloxacin, cisapride, clarithromycin, clonidine, clopidogrel, cyclobenzaprine, cyproheptadine, delavirdine, desmopressin, diltiazem, dipyridamole, dolasetron, enalapril maleate, enalaprilat, famotidine, felodipine, furazolidone, glipizide, irbesartan, ketoconazole, lansoprazole, loratadine, loxapine, mebendazole, mercaptopurine, milrinone lactate, minocycline, mitoxantrone, nelfinavir mesylate, nimodipine, norfloxacin, olanzapine, omeprazole, penciclovir, pimozide, tacolimus, quazepam, raloxifene, rifabutin, rifampin, risperidone, rizatriptan, saquinavir, sertraline, sildenafil, acetyl-sulfisoxazole, temazepam, thiabendazole, thioguanine, trandolapril, triamterene, trimetrexate, troglitazone, trovafloxacin, verapamil, vinblastine sulfate, mycophenolate, atovaquone, atovaquone, proguanil, ceftazidime, cefuroxime, etoposide, terbinafine, thalidomide, fluconazole, amsacrine, dacarbazine, teniposide, and acetylsalicylate.

42. The method of claim 26, wherein the subject is a human.

43. The method of claim 26, wherein the method is used to treat indications where blood-glucose lowering drugs are typically used.

44. The method of claim 26, wherein the method is used to treat diabetes.

45. The method of claim 44, wherein the diabetes is non-insulin dependent diabetes mellitus.

46. The composition of claim 1, wherein: (i) the surface stabilizer is hydroxypropyl cellulose; and (ii) the composition is formulated into a fast melt formulation, which disintegrates in less than 1 minute upon contact with water.

47. The composition of claim 1, wherein: (i) the surface stabilizer is hydroxypropyl cellulose; and (ii) the composition is formulated into a controlled release formulation.

48. The composition of claim 47, wherein the controlled release formulation of the composition has a steady release over a time period of about 16 hours.

49. The composition of claim 47, wherein the controlled release formulation of the composition is uncoated and has a steady release over a time period of about 22 hours.
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