Journal Publications and Abstracts

Glumetza®  for Type 2 Diabetes

Schwartz SL, Gordi T, Hou E, Cramer M, Heritier M, Cowles VE. Clinical development of metformin extended-release tablets for type 2 diabetes: an overview. Expert Opin Drug Metab Toxicol 2008 Sep;4(9):1235-43.
Lewin A, Lipetz R, Wu J, Schwartz S. Comparison of extended-release metformin in combination with a sulfonylurea (glyburide) to sulfonylurea monotherapy in adult patients with type 2 diabetes: a multicenter, double-blind, randomized, controlled, phase III study. Clinical Therapeutics 2007; 29(5):844-855.
Foster RH, Keam SJ. Metformin extended-release. American Journal of Drug Delivery. 4(3):177-186, 2006.
Schwartz S, Wu J, Berner B. Extended-release metformin for the treatment of type 2 diabetes mellitus. Expert Opinion on Pharmacotherapy 2006; 7(6):803-809.
Schwartz S, Fonseca V, Berner B, Cramer M, Chiang Y-K, Lewin A. Efficacy, tolerability, and safety of a novel once-daily extended-release metformin in patients with type 2 diabetes. Diabetes Care 2006; 29(4):759-764.
Gusler G, Gorsline J, Levy G, Zhang SZ, Weston IE, Naret D, et al. Pharmacokinetics of metformin gastric-retentive tablets in healthy volunteers. J Clin Pharmacol 2001; 41(6):655-61.
Hankin C, Wang Z, Bronstone A, Cramer, M, Berner B, Chiang Y, Wu J. Role of gender on response to anti-hyperglycemic medications. American Society of Health-System Pharmacists. Anaheim, CA, December 2006.
Kasichayanula S, Berner B, He J, Campanella C. Novel metformin HCl extended-release tablets: pharmacokinetics and pharmacodynamics in subjects with normal renal function and in subjects with mild and moderate renal impairment. AAPS Annual Meeting, 2006.
Hankin C, Berner B, Wu J, Wang Z, Bronstone A.Disparity in Response to Metformin among Obese versus Non-Obese Patients with Type 2 Diabetes. World Congress on Controversies in Obesity, Diabetes, and Hypertension. Berlin, Germany, October 2006.
Hankin CS, Berner B, Wu J. Comparison of treatment persistence with two formulations of metformin. 28th Annual Meeting Society for Medical Decision Making, Cambridge, MA. October 2006.
Schwartz S, Berner B, Cramer M, Chiang Y-K, Lewin A. Addition of once-daily extended-release metformin to sulfonylurea significantly improves glycemic control in patients with type 2 diabetes. Diabetes 2006; 55 (suppl 1; 66th Scientific Sessions Abstract Book):1999-PO.
Hou SYE, Gusler GM, Wilding IR, Connor AL, Hughes N, Cowles VE, Berner B. Gastric Retention and Pharmacokinetics of a Novel Extended-Release Metformin Formulation. Endocrine Society 88th Annual Meeting; 2006; Abstract no. 905.
Zhang S, Hou SYE, Gusler GM, Berner B. Dissolution of metformin from extended-release tablets differs significantly between formulations. Endocrine Society 88th Annual Meeting; 2006; Abstract no. 2798.
Fleming GA, Berner B, Cramer M, Chiang Y-K, Schwartz SL. Randomized, double-blind, parallel-group study to assess the comparative efficacy, safety, and tolerability of extended-release (ER) and immediate release (IR) metformin formulations. Endocrine Society 86th Annual Meeting; 2004; Abstract no. 852443.
Gusler GM, Hou SYE, Connor AL, Wilding IR, Berner B. Pharmacoscintigraphic evaluation of metformin ER in healthy volunteers. AAPS Annual Meeting; 2003.

 

Proquin®XR for Uncomplicated Urinary Tract Infections

Hou S, Yeh J, Fell R.  In vitro release of ciprofloxacin from extended-release tablets.  The AAPS Journal 10 (S2), 2008.
Washington CB, Hou SYE, Hughes N, Berner B. Effect of omeprazole on bioavailability of an oral extended-release formulation of ciprofloxacin. Am J Health System Pharmacy 2006; 63:653-656.
Washington CB, Hou SY, 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(11):1236-44.
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 infection in women. Antimicrob Agents Chemother 2005; 49(10):4137-43.
Fourcroy J, Berner B, Chiang Y, Cramer M, Rowe L, Shore N. Efficacy and safety of Proquin XR™ (gastric-retentive ciprofloxacin [C-GR]) vs. immediate release ciprofloxacin (C-IR) in the treatment of uncomplicated urinary tract infection (uUTI). Interscience Conference on Antimicrobial Agents and Chemotherapy, 2004.
Berner B, Cramer M, Chiang Y, Louie-Helm J. Randomized, double-blind comparison of the safety and efficacy of novel, once-daily extended-release ciprofloxacin in uncomplicated urinary tract infection. J Urology 2004; 171(4S):25 (Abstract).
Hou SYE, Washington CB, Kaltagian P, Campanella C, Hughes N, Mysicka J, et al. Pharmacokinetics (PK) and pharmacokinetics/pharmacodynamics (PD) of ciprofloxacin HCl extended-release (C-GR, Proquin™ XR) tablets following single and steady-state dosing in healthy volunteers. AAPS Annual Meeting, 2004.
Louie-Helm J, Berner B, Fell R, Shell JN, Dye D, Levy G, et al. Pharmacokinetics of ciprofloxacin gastric retentive tablets in healthy volunteers. Control Release Society 28th Annual Meeting Proceedings 2001; 6044.

 

DM-5689 – Clinical-stage Product Candidate for Hot Flashes

Sweeney M, Sathyanarayana R, Gordi T, Cowles VE, Heritier M. Positive Efficacy data from a phase 2 trial of gabapentin extended-release in the treatment of menopausal hot flashes.  Menopause; 15(6): 1225, 2008.
Gordi T, Cowles V, Chiang YK, Hou E. Gabapentin pharmacokinetics after the administration of a gastric retentive formulation in post-menopausal women with hot flashes. The AAPS Journal 10 (S2), 2008.

 

DM-1796 – Clinical-stage Product Candidate for Pain 

Sandercock,D, Cramer,M, Wu,J, Chiang,YK, Biton,V, Heritier,M. Gabapentin extended release for the treatment of painful diabetic peripheral neuropathy: efficacy and tolerability in a double-blind, randomized, controlled clinical trial.  Diabetes Care; 32(2) e20, 2009.
Schwartz S, BernerB, CramerM, ChiangY-K, BitonV, and SandercockD. Efficacy of once-daily extended-release gabapentin for the treatment of painful diabetic neuropathy. 67th Annual Meeting of the American Diabetes Association, 2007.
Gordi T, Hou E, Berner B. Pharmacokinetics of Gabapentin After Single and Repeated Dosing of Gabapentin Extended Release Tablets (G-ER) and Neurontin® (IR) Tablets in Healthy Male and Female Volunteers. 34th Controlled Release Society Annual Meeting, 2007.
Irving G, Berner B, Wu, J, Cramer M, Chiang Y-K, Minehart M, Jensen M. Efficacy and safety of extended-release gabapentin for the treatment of postherpetic neuralgia. 9th International Conference on Mechanisms and Treatment of Neuropathic Pain, 2006.
Cowles, V, Gussler, G, Gu R, Louie-Helm J, Hou E, Berner B. Dose proportionality of gabapentin gastric retentive extended-release tablets in Beagle dogs. AAPS Annual Meeting, 2006.
Gordi T, Savic R, Hou E, Karlsson MO, Berner B. A mechanistic model for gabapentin pharmacokinetics after immediate release and extended release formulations. AAPS Annual Meeting, 2006.
Gu R, Gusler GM, Hou SYE, Washington CB, Hughes N, Wu JF, Berner B. Extended-release and dose-proportionality of a novel gabapentin formulation. Endocrine Society 88th Annual Meeting; 2006; Abstract no. 1194.
Enriquez A, Low C, Myrback RE, Gusler G, Hou SYE, Berner B, Cowles VE. Comparison of the pharmacokinetics of gabapentin gastric retentive (GRÔ) tablets versus an immediate release capsule in Beagle dog. Controlled Release Society 31st Annual Meeting Proceedings, 2004; 177.

 

DM-3458 – Clinical-stage Product Candidate for GERD

Cowles VE, Hou SYE, Fell R, Gordi T, Gu R, Evans P, Church A, Connor A, Wilding I, Berner B.  A Pharmacoscintigraphic Study to Assess the Performance of Novel Gastro-retentive Pulsatile Formulations of Esomeprazole in Human.  Control Release Society 35th Annual Meeting Proceedings 58, 2008.
Cowles VE, Hou SYE, Fell R, Connor A, Evans P, Wilding I, Berner B. Absorption of Omeprazole from the Gastrointestinal Tract. The AAPS Journal 10 (S2), 2008.

 

Technologies

Gordi T, Hou E, Kasichayanula S, Berner B. Pharmacokinetics of gabapentin after a single day and at steady state following the administration of gastric-retentive- extended-release and immediate-release tablets: A randomized, open-label, multiple-dose, three-way crossover, exploratory study in healthy subjects. Clin Ther 2008 May;30(5):909-16.
Berner B, Cowles V. Case studies in swelling polymeric gastric retentive tablets. Expert Opin Drug Deliv 2006;3:541-548.
Wu, J. Gastric retentive dosage forms. Scrip Drug Delivery Supplement. 2005;18-19.
Shojaei AH, Berner B. Gastric retentive dosage forms; in Li X and Jasti B. Design of Controlled Release Drug Delivery Systems. McGraw Hill, NY, pp. 175-203 (2005).
Hou SYE, Cowles VE, Berner B. Gastric retentive dosage forms: a review. Crit Rev Ther Drug Carrier Syst 2003; 20(6):459-97.
Heaney RP, Berner B, Louie-Helm J. Dosing regimen for calcium supplementation. J. Bone Mineral Res 15:2291 (2000) [Letter to the editor].
Berner B, Cramer M, Chiang Y-K, Rowe L, Smithh WB, Hou SYE, Cowles VE, Gusler G, Wilding, IR. Pharmacokinetic and clinical case studies on gastric retentive (GR™) tablets. Controlled Release Society 2006
Wilson AM, McKenna B, Gudipati M, Desmond A, Prosser E, Cumming KI, et al. Evaluation of endogastric therapeutic system (EGTS) containing a GABA receptor agonist in dogs. AAPS Pharm Sci 2001; 3(S1).
Cumming KI, Wilson AM, McKenna B, Conaghey O, Desmond A, Ramtoola Z, et al. The pharmacokinetics and pharmacoscintigraphic evaluation of endogastric therapeutic system (EGTS) in fasted and fed state in healthy humans. AAPS Pharm Sci 2001; 3(S1).
Cowles VE, Gusler G, Chen TF, Hou SYE, 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.
Berner B, Hou SYE, Cowles VE. Gastric retentive dosage forms: a review with a focus on the fed mode. Controlled Release Society 31st Annual Meeting Proceedings, 2004; 50.