Case studies in swelling polymeric gastric retentive tablets

Expert Opinion on Drug Delivery

Volumn 3, Issue 4, 2006, Pages 541-548

  Berner, Bret ^a   Cowles, Verne E ^a  

^a Pharmacokinetics Depomed Inc   (United States)

Author keywords

Controlled release; Extended release; Food effect; Gastric retentive; Oral drug delivery

Indexed keywords

CIPROFLOXACIN; DRUG CARRIER; FUROSEMIDE; METFORMIN; POLYMER;

ARTICLE; CHEMISTRY; ENTERIC COATED TABLET; GASTROINTESTINAL TRACT; HUMAN; ORAL DRUG ADMINISTRATION; PHYSIOLOGY;

ADMINISTRATION, ORAL; CIPROFLOXACIN; DRUG CARRIERS; FUROSEMIDE; GASTROINTESTINAL TRACT; HUMANS; METFORMIN; POLYMERS; TABLETS, ENTERIC-COATED;

EID: 39049179556     PISSN: 17425247     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425247.3.4.541     Document Type: Review

References (40)

1. MOES A: Gastroretentive dosage forms. Crit. Rev. Ther. Drug Carrier Syst. (1993) 10:143-195. (Pubitemid 23198886)
2. HWANG SJ, PARK H, PARK K: Gastric retentive drug-delivery systems. Crit. Rev. Ther. Drug Carrier Syst. (1998) 15:243-284. •• A review that covers the literature on gastric retentive devices at the time of publication.
3. SINGH BN, KIM KH: Floating drug delivery systems: an approach to oral controlled drug delivery via gastric retention. J. Control. Release (2000) 63:235-259.
4. HOU SY, COWLES VE, BERNER B: Gastric retentive dosage forms: a review. Crit. Rev. Ther. Drug Carrier Syst. (2003) 20:461-497. •• Another review that covers the literature on gastric retentive devices at the time of publication.
5. MASON GR, KAHRILAS PJ, OTTERSON MF et al.: The digestive system. In: The Physiologic Basis of Surgery (2nd edn). JP O'Leary (Ed.), Williams and Wilkens, Baltimore, MD, USA (1996):406-440.
6. SARNA SK, OTTERSON MR, COWLES VE, TELFOR GL: Myogenic, neural and chemical control of small intestinal motor activity. In: Essentials of Experimental Surgery: Gastroenterology (Chapter 9). SL Jensen, H Gregerson, MS Amiri, F Moody, (Eds), Harwood Academic Publishers, Reading, UK (1996):1-21.
7. MOCKIKI E, KUWANO H, NAKABAYASHI T, GARCIA M, HAGA N, ASAO T: Pyloric relaxation regulated via intramural neural pathway of the antrum. Dig. Dis. Sci. (2001) 46:2307-2313. (Pubitemid 33042325)
8. COWLES VE, NELLANS HN, SEIFERT TR et al.: Effect of novel motilide ABT-229 versus erythromycin and cisapride on gastric emptying in dogs. J. Pharmacol Exp. Ther. (2000) 293:1106-1111. (Pubitemid 30417882)
9. MEYER JH: Motility of the stomach and gastroduodenal junction. In: Physiology of the Gastrointestinal Tract (Vol. 1, 2nd edn). LR Johnson, (Ed.), Raven Press, New York, NY, USA (1987): 613-629.
10. HOUGHTON LA, READ NW, HEDDLE R et al.: Relationship of motor activity of the antrum, pylorus, and duodenum to gastric emptying of a solid-liquid mixed meal. Gastroenterology (1988) 94:1285-1291. (Pubitemid 18153626)
11. MUNK JF, GANNAWAY RM, HOARE M, JOHNSON AG: Direct measurement of pyloric diameter and tone in man and their response to cholecystokinin. In: Gastrointestinal Motility in Health and Disease. HL Duthie (Ed.), MTP, Lancaster, UK (1978):349-359.
12. TIMMERMANS J, MOES AJ: The cutoff size for gastric emptying of dosage forms. J. Pharm. Sci. (1993) 82:854. (Pubitemid 23314097)
13. TIMMERMANS J, MOES AJ: Factors controlling the buoyancy and gastric retention capabilities of floating matrix capsules: new data for reconsidering the controversy. J. Pharm. Sci. (1994) 83:18-24. (Pubitemid 24233723)
14. COWLES VE, GUSLER G, CHEN TF, HOU SY, WILDING I, BERNER B: Gastric emptying and intestinal transit of gastroretentive tablets in the fed state: effect of meal content and tablet size. Gastroenterology (2004) 126(Suppl. 2):A489-A490.
15. GUSLER G, GORSLINE J, LEVY G et al.: Pharmacokinetics of metformin gastric-retentive tablets in healthy volunteers. J. Clin. Pharmacol. (2001) 41:1-7. (Pubitemid 32493360)
16. GUSLER G, HOU SY, CONNOR AL, WILDING IR, BERNER B: Pharmacoscintigraphic evaluation of metformin ER in healthy volunteers. Pharm. Sci. (2003) 5:S1.
17. MARATHE PH, ARNOLD ME, MEEKER J, GREENE DS, BARBHAIYA RH: Pharmacokinetics and bioavailability of a metformin/glyburide tablet administered alone and with food. J. Clin. Pharmacol. (2000) 40(12 Pt 2):1494-1502. (Pubitemid 30846552)
18. VIDON N, CHAUSSADE S, NOEL M, FRANCHISSEUR C, HUCHET B, BERNIER JJ: Metformin in the digestive tract. Diabetes Res. Clin. Pract. (1988) 4(3):223-229. (Pubitemid 18080749)
19. HARDER S, FUHR U, BEERMANN D, STAIB AH: Ciprofloxacin absorption in different regions of the human gastrointestinal tract. Investigations with the hf-capsule. Br. J. Clin. Pharmacol. (1990) 30(1):35-39. (Pubitemid 20225452)
20. CLEAR NJ, MILTON A, HUMPHREY M et al.: Evaluation of the intelisite capsule to diliver theophylline and frusemdie tablets to the small intestine and colon. Eur. J. Pharm. Sci. (2001) 13(4):375-384. (Pubitemid 32618646)
21. RILEY SA, KIN M, SUTCLIFFE F, ROWLAND M, TURNBERG LA: Absorption of polar drugs following caecal instillation in healthy volunteers. Aliment. Pharmacol. Ther. (1992) 6(6):701-706. (Pubitemid 23004318)
22. CUBEDDU LX, BONISCH H, GOTHERT M et al.: Effects of metformin on intestinal 5-hydroxytryptamine (5-HT) release and on 5-HT3 receptors. Naunyn. Schmiedebergs Arch. Pharmacol. (2000) 361(1):85-91. (Pubitemid 30064659)
23. Physicians' Desk Reference (57th edn). Thomson PDR, Montvale, NJ, USA (2003):1084.
24. DUNN CJ, PETERS DH: Metformin. A review of its pharmacological properties and therapeutic use in non-insulin-dependent diabetes mellitus. Drugs (1995) 49:721-749. • A review that discuses the pharmacology of metformin and the benefits concerning the side effect profile of giving smaller doses more often.
25. SCHWARTZ S, FONSECA V, BERNER B, CRAMER M, CHIANG YK, LEWIN A: Efficacy, tolerability, and safety of a novel once-daily extended-release metformin in patients with Type 2 diabetes. Diabetes Care (2006) 29:1-6. (Pubitemid 44115290)
26. SCHEEN AJ: Clinical pharmacokinetics of metformin. Clin. Pharmacokinet. (1996) 30(5):359-371 (Pubitemid 26177181)
27. SCHWARTZ S, WU J, BERNER B: Extended-release metformin for the treatment of diabetes mellitus. Expert Opin. Pharmacother. (2006) 7(6):803-809.
28. FUJIOKA K, BRAZG RL, RAZ I et al.: Efficacy, dose-response relationship and safety of once-daily extended-release metformin (Glucophage XR) in Type 2 diabetic patients with inadequate glycaemic control despite prior treatment with diet and exercise: results from two double-blind, placebo-controlled studies. Diabetes Obes. Metab. (2005) 7(1):28-39.
29. LOUIE-HELM J, FELL R, GUSLER G et al.: Dual-labelled pharmacoscintigraphic study of furosemide gastric retentive (GR™) tablets in healthy volunteers. CRS 30th Annual Meeting Proceedings Glasgow, Scotland (2003):118.
30. BLONDEAU JM: Current issues in the management of urinary tract infections:extended-release ciprofloxacin as a novel treatment option. Drugs (2004) 64:611-628. (Pubitemid 38482441)
31. DAVIS R, MARKHAM A, BALFOUR JA: Ciprofloxacin. An updated review of its pharmacology, therapeutic efficacy and tolerability. Drugs (1996) 51:1019-1074. (Pubitemid 126444217)
32. AMINIMANIZANI A, BERINGER P, JELLIFFE R: Comparative pharmacokinetics and pharmacodynamics of the newer fluoroquinolone antibacterials. Clin. Pharmacokinet. (2001) 40(3):169-187. (Pubitemid 32324449)
33. TURNIDGE J: Pharmacokinetics and pharmacodynamics of fluoroquinolones. Drugs (1999) 58(Suppl. 2):29-36. • A review article that provides the parameters that must be met in order to develop an effective C-ER formulation.
34. LEUNG WK, CHAN FK, FUNG SS, WONG MY, SUNG JJ: Effect of oral erythromycin on gastric and small bowel transit time endoscopy. World J. Gastroenterol. (2005) 11:4865-4868. (Pubitemid 41223299)
35. WASHINGTON CB, HOU E, CAMPANELLA C, HUGHES N, BROWN S, BERNER B: Pharmacokinetics and pharmacodynamics of a novel extended-release ciprofloxacin in healthy volunteers. J. Clin. Pharmacol. (2005) 45:1236-1244. (Pubitemid 41513046)
36. FOURCROY JL, BERNER B, CHIANG YK, CRAMER M, ROWE L, SHORE N: Efficacy and safety of a novel once daily extended-release ciprofloxacin tablet formulation for treatment of uncomplicated urinary tract infections in women. Antimicrob. Agents Chemother. (2005) 49:4137-4143. (Pubitemid 41400956)
37. BRATER DC: Clinical pharmacology of loop diuretics. Drugs (1991) 41(Suppl. 3):14-22. • An article that presents the rationale for an F-ER formulation.
38. DEPOMED, INC: US20030091630 (2003).
39. DEPOMED, INC: US6451808 (2002).
40. http://www.metsol.com/gastric-emptying-validation.htm Metabolic Solutions Inc. Gastric Motility Breath Test Validation (2006).