scholarly journals Comparison of dissolution profile of extended-release oral dosage forms - two one-sided equivalence test

2013 ◽  
Vol 49 (2) ◽  
pp. 367-371 ◽  
Author(s):  
Felipe Rebello Lourenço ◽  
Daniela Dal Molim Ghisleni ◽  
Rosa Noriko Yamamoto ◽  
Terezinha de Jesus Andreoli Pinto
Keyword(s):  
Extended Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Dissolution Profile ◽  
Equivalence Test ◽  
Significance Level ◽  
Similarity Factor ◽  
Alternative Approach ◽  
Oral Dosage Forms ◽  
States Pharmacopeia

The aim of this work is to present the two one-sided test (TOST) as an alternative approach to compare dissolution profiles of extended-release dosage forms. The dissolution profiles of oxycodone extended-release tablets containing 10 mg, 20 mg and 40 mg (reference and generic) were evaluated according to the requirements described in United States Pharmacopeia. These dissolution profiles were compared using the conventional similarity factor (f2) and the proposed TOST as an equivalence test. TOST is a simple and alternative approach to compare dissolution profiles of extended-release dosage forms. It allows us to identify the time-point (or time-points) that did not show similarity. We concluded that the two one-sided test performed at a significance level of 5% and defined as D = 10 showed results comparable to those obtained by the conventional similarity factor (f2).

scholarly journals FDA Guidance for Industry 1 Extended Release Solid Oral Dosage forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations

1997 ◽  
Vol 4 (4) ◽  
pp. 23-32 ◽  
Author(s):  
Henry Malinowski ◽  
Patrick Marroum ◽  
Venkata Ramana Uppoor ◽  
William Gillespie ◽  
Hae-Young Ahn ◽  
...  
Keyword(s):  
Extended Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Fda Guidance ◽  
Solid Oral Dosage Forms ◽  
Development Evaluation ◽  
Oral Dosage Forms

Thein vitro development of extended-release solid oral dosage forms

1985 ◽  
Vol 13 (5) ◽  
pp. 493-514 ◽  
Author(s):  
Lewis J. Leeson ◽  
Dennis Adair ◽  
James Clevenger ◽  
Nora Chiang
Keyword(s):  
Extended Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms ◽  
Vitro Development

scholarly journals Recent Patents on Modified Release Oral Dosage Forms

2021 ◽  
Vol 11 (4-S) ◽  
pp. 195-211
Author(s):  
Atul Pund ◽  
Atishkumar Mundada ◽  
Manoj Magar ◽  
Abhijeet Kadam
Keyword(s):  
Controlled Release ◽  
Sustained Release ◽  
Extended Release ◽  
Dosage Forms ◽  
Delivery Systems ◽  
The Body ◽  
Oral Dosage ◽  
Modified Release ◽  
Delayed Release ◽  
Oral Dosage Forms

Background: Conventional oral dosage forms have limited bioavailability and frequent dosing of the drug is needed to maintain the effective therapeutic concentration in the body. This results in poor patient compliance and fluctuations in the plasma drug levels, especially in the chronic diseases and disorders. Objective: To overcome such problems and to enhance the efficiency and bioavailability of the drug, modified drug delivery systems such as extended release delivery systems (controlled release; sustained release) and delayed release delivery systems are developed which can prolong the release and hence action of the drug in the body. Methods: Through this review, we throw the light on recent patents and patent applications on modified release systems pertaining to oral dosage forms.  The various free patent search databases were used to collect and analyze the information on modified release delivery systems. Results: Modified release systems such as extended release and delayed release delivery systems have been found to be of great significance due to their advantages over immediate release dosage forms. These systems are formulated using various approaches, different types of release controlling polymers such as natural, semisynthetic and synthetic polymers and found to avoid the limitations of conventional oral dosage forms. Conclusion: Modified drug release systems have potential especially, in case of the chronic diseases, mental health disorders and lifestyle diseases and disorders. These systems have unique commercial advantages which will sustain the interest of both the researchers and the pharmaceutical companies. Keywords: Modified release systems, extended release systems, controlled release systems, sustained release systems, delayed release systems, oral dosage forms, multilayer dosage form, multilayered tablets

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