Glaxo's Experience of Different Absorption Rate Metrics of Immediate Release and Extended Release Dosage Forms

1995 ◽  
Vol 29 (3) ◽  
pp. 821-840 ◽  
Author(s):  
Larry F. Lacey ◽  
Alan Bye ◽  
Oliver N. Keene
Keyword(s):  
Absorption Rate ◽  
Extended Release ◽  
Immediate Release ◽  
Dosage Forms

scholarly journals Gliclazide: Biopharmaceutics Characteristics to Discuss the Biowaiver of Immediate and Extended Release Tablets

2020 ◽  
Vol 10 (20) ◽  
pp. 7131
Author(s):  
Bruna de Carvalho Mapa ◽  
Lorena Ulhôa Araújo ◽  
Neila Márcia Silva-Barcellos ◽  
Tamires Guedes Caldeira ◽  
Jacqueline Souza
Keyword(s):  
Extended Release ◽  
Immediate Release ◽  
Pharmacokinetic Profile ◽  
Dosage Forms ◽  
New Drugs ◽  
Essential Medicines ◽  
World Health ◽  
Drug Candidate ◽  
Dissolution Profile ◽  
First Choice

The lists of essential medicines of the World Health Organization (WHO) and Brazil include gliclazide as an alternative to the oral antidiabetic drug of first choice, metformin, in the treatment of type 2 diabetes mellitus because of its pharmacokinetic profile and few side effects. Thus, it is also considered by WHO and the International Pharmaceutical Federation (FIP) as a drug candidate to biowaiver, which is the evaluation of how favorable the biopharmaceutics characteristics are in order to obtain waiver from the relative bioavailability/bioequivalence (RB/BE) studies to register new medicines. This paper presents a review about the solubility, permeability and dissolution of gliclazide. A critical analysis of the information allowed to identify gliclazide as a Biopharmaceutics Classification System (BCS) Class II drug. Therefore, new drugs in immediate release dosage forms will not be eligible for biowaiver. Regarding the extended release dosage forms, besides the limited solubility, no information on the comparative dissolution profile was found, which would be necessary to analyze a possible biowaiver for a smaller dosage. It can be concluded that the registration of new medicines containing gliclazide must undergo RB/BE studies, since there is not enough evidence to recommend the replacement and waiver of such studies for immediate and extended release formulations.

scholarly journals Urinary Incontinence during Sleep Associated with Extended Release Form of Bupropion HCI

2015 ◽  
Vol 2015 ◽  
pp. 1-3
Author(s):  
Filiz Izci ◽  
Merve Iris Koc ◽  
Rabia Bilici ◽  
Murat Yalcin ◽  
Engin Emrem Bestepe
Keyword(s):  
Urinary Incontinence ◽  
Side Effect ◽  
Extended Release ◽  
Immediate Release ◽  
Dosage Forms ◽  
Side Effect Profile ◽  
Dopamine Reuptake ◽  
Safe Side ◽  
Dopamine Reuptake Inhibitor ◽  
Release Form

Bupropion hydrochloride (HCI) is an antidepressant that acts as a norepinephrine and dopamine reuptake inhibitor and has three different dosage forms including immediate release (IR), sustained release (SR), and extended release (ER). Despite its relatively safe side effect profile bupropion may cause several side effects. Here, we aimed to report a case with major depression using extended release form of bupropion hydrochloride who was presented with urinary incontinence during sleep, an uncommon side effect of bupropion.

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Piroxicam

2014 ◽  
Vol 103 (2) ◽  
pp. 367-377 ◽  
Author(s):  
Igor E. Shohin ◽  
Julia I. Kulinich ◽  
Galina V. Ramenskaya ◽  
Bertil Abrahamsson ◽  
Sabine Kopp ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

scholarly journals Benznidazole Extended-Release Tablets for Improved Treatment of Chagas Disease: Preclinical Pharmacokinetic Study

2016 ◽  
Vol 60 (4) ◽  
pp. 2492-2498 ◽  
Author(s):  
Marcelo Gomes Davanço ◽  
Michel Leandro Campos ◽  
Talita Atanazio Rosa ◽  
Elias Carvalho Padilha ◽  
Alejandro Henao Alzate ◽  
...  
Keyword(s):  
Chagas Disease ◽  
Extended Release ◽  
Hydroxypropyl Methylcellulose ◽  
Immediate Release ◽  
Relative Bioavailability ◽  
Pharmacokinetic Parameters ◽  
Therapeutic Success ◽  
Preclinical Pharmacokinetics ◽  
Bioavailability Study

ABSTRACTBenznidazole (BNZ) is the first-line drug for the treatment of Chagas disease. The drug is available in the form of immediate-release tablets for 100-mg (adult) and 12.5-mg (pediatric) doses. The drug is administered two or three times daily for 60 days. The high frequency of daily administrations and the long period of treatment are factors that significantly contribute to the abandonment of therapy, affecting therapeutic success. Accordingly, this study aimed to evaluate the preclinical pharmacokinetics of BNZ administered as extended-release tablets (200-mg dose) formulated with different types of polymers (hydroxypropyl methylcellulose K4M and K100M), compared to the tablets currently available. The studies were conducted with rabbits, and BNZ quantification was performed in plasma and urine by ultraperformance liquid chromatography methods previously validated. The bioavailability of BNZ was adequate in the administration of extended-release tablets; however, with the administration of the pediatric tablet, the bioavailability was lower than with other tablets, which showed that the clinical use of this formulation should be monitored. The pharmacokinetic parameters demonstrated that the extended-release tablets prolonged drug release from the pharmaceutical matrix and provided an increase in the maintenance of the drug concentrationin vivo, which would allow the frequency of administration to be reduced. Thus, a relative bioavailability study in humans will be planned for implementation of a new product for the treatment of Chagas disease.

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Quinine Sulfate

2012 ◽  
Vol 101 (2) ◽  
pp. 499-508 ◽  
Author(s):  
Stefanie Strauch ◽  
Jennifer B. Dressman ◽  
Vinod P. Shah ◽  
Sabine Kopp ◽  
James E. Polli ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Quinine Sulfate ◽  
Oral Dosage ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms
Sign in / Sign up

Export Citation Format

Share Document