Challenges of fixed dose combination products development

American Pharmaceutical Review

Volumn 10, Issue 2, 2007, Pages

  Luo, Yi ^a   Zu, Yanming ^a   Ahmed, Salah U ^a  

^a Research and Development

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID PLUS BUTALBITAL PLUS CAFFEINE; ACETYLSALICYLIC ACID PLUS DIPYRIDAMOLE; AMLODIPINE PLUS BENAZEPRIL; AMOXICILLIN PLUS CLAVULANIC ACID; ARTHRONEC; BETAMETHASONE DIPROPIONATE; CAFERGOT; CARBIDOPA PLUS LEVODOPA; CETIRIZINE; CHLORPHENIRAMINE MALEATE; CIPROFLOXACIN; CLARINASE REPETABS; CLOTRIMAZOLE; CODEINE; CORTICOSPORIN; CORTISPORIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DORZOLAMIDE PLUS TIMOLOL; ENALAPRIL MALEATE PLUS FELODIPINE; ESTRADIOL CYPIONATE PLUS MEDROXYPROGESTERONE ACETATE; ESTRADIOL PLUS LEVONORGESTREL; ETHINYLESTRADIOL PLUS NORELGESTROMIN; FEXOFENADINE; FLUTICASONE PROPIONATE PLUS SALMETEROL; GENTAMICIN; HYDROCHLOROTHIAZIDE; HYDROCHLOROTHIAZIDE PLUS TELMISARTAN; HYDROCODONE BITARTRATE; HYDROCODONE BITARTRATE PLUS PARACETAMOL; HYDROCORTISONE; IBUPROFEN PLUS OXYCODONE; IPRATROPIUM BROMIDE PLUS SALBUTAMOL SULFATE; LIDOCAINE; LOPINAVIR PLUS RITONAVIR; ORAQIX; PRED G; PREDNISOLONE; PRILOCAINE; TELMISARTAN; TUSSIONEX PENNKINETIC; UNCLASSIFIED DRUG; UNINDEXED DRUG; ZYRTEC D;

ANALYTIC METHOD; CLINICAL EFFECTIVENESS; COST; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; FOOD AND DRUG ADMINISTRATION; HUMAN; PATIENT COMPLIANCE; REVIEW; TABLET;

EID: 55749098810     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (24)

1. Wertheimer AI, Morrison A. Combination drugs: innovation in pharmacotherapy. P&T 2002; 27(1):44-49.
2. Dubin CH. Combination products: strategies for a continuous pipeline. Drug Del. Tech. 2005; 5(9):41-46.
3. http://www.rxlist.com.
4. Chrysant SG. Fixed low-dose drug combination for the treatment of hypertension. Arch. Fam. Med. 1998; 7:370-376.
5. Moulding T, Dutt AK, Reichman LB. Fixed-dose combinations of antituberculous medications to prevent drug resistance. Ann. Intern. Med. 1995; 122(12):951-954.
6. Young B, Greenberg KS. Effective regimens for treatment of HIV, business briefing. Nor. Am. Pharmacotherapy 2004; 2:1-5.
7. Laing RO, McGoldrick K. Tuberculosis drug issues: prices, fixed dose combination products and second line drugs. North American regional meeting of the International Union against Tuberculosis and Lung Disease. February 26th 2000, Vancouver.
8. Thayer AM. Fighting malaria. Chem. Engineering News 2005; 83(43):69-82.
9. DeFronzo RA. Pharmacologic therapy for type 2 diabetes mellitus. Ann. Intern. Med. 1999; 131:281-303.
10. Insull W Jr, McGovern ME, Schrott H, Thompson P, Crouse JR, Zieve F, Corbelli J. Efficacy of extended-release niacin with lovastatin for hypercholesterolemia: assessing all reasonable doses with innovative surface graphaAnalysis. Arch. Intern. Med. 2004; 164:1121-1127.
11. Raffa R.B. Pharmacology of oral combination analgesics: rational therapy for pain. J. Clin. Pharm. Ther. 2001; 26:257-264.
12. Hamacher T, Schinzel M, Scholzel-Klatt A, Neff HM, Maier H, Schlaffer G, Beausencourt E, Jutte M, Scholz R, Lorger C, Stewart WC. Short term efficacy and safety in glaucoma patients changed to the latanoprost 0.005%/timolol maleate 0.5% fixed combination from monotherapies and adjunctive therapies. Br. J. Ophthalmol. 2004; 88(10):1295-1298.
13. Lee NP, Arriola ER. How to treat allergic rhinitis. West J. Med. 1999; 171:31-34.
14. Lenz TL, Hilleman DE. Aggrenox: a fixed-dose combination of aspirin and dipyridamole. Ann. Pharmacotherapy 2002; 34(11):1283-1290.
15. Hauser RA. Levodopa/carbidopa/entacapone (Stalevo). Neurology. 2004; 62(1 suppl 1):S64-S71.
16. Shelton RC. Olanzapine/fluoxetine combination for bipolar depression. Expert Rev. Neurother. 2006; 6(1):33-39.
17. Martinelli I, Battaglioli T, Mannucci PM, Sutherland SE, Munarriz RM, Goldstein I, Petitti DB. Combined estrogen-progestin oral contraceptives. N. Engl. J. Med. 2004; 350:307-308.
18. Wechsler J. Combination products raise manufacturing challenges: new fixed-dose combination drugs aim to enhance safety and efficacy, while regulators clear a path for more drug-device combination products. Pharm. Tech. 2005; March:32-40.
19. Kramer MD. Combination products: challenges and progress. Regulatory Affairs Focus 2005; August:30-35.
20. http://www.fda.gov/cder/approval/index.htm
21. http://www.innercap.com
22. Agrawal S, Panchagnula R. Dissolution test as a surrogate for quality evaluation of rifampicin containing fixed dose combination formulations. Int. J. Pharm. 2004; 287:97-112.
23. http://www.fda.gov/ cder/guidance/5629dft.pdf
24. Cvetkovic RS, Plosker GL. Ramipril/felodipine extended-release fixed-dose combination: a review of its use in the management of essential hypertension. Drugs 2005; 65(13):1851-1868.