In-vivo and in-vitro evaluations of a modified-release oral dosage form of nifedipine by hybridization of hydroxypropyl-β-cyclodextrin and hydroxypropylcelluloses in dogs

1994 ◽  
Vol 46 (6) ◽  
pp. 505-507 ◽  
Author(s):  
ZHENG WANG ◽  
FUMITOSHI HIRAYAMA ◽  
KANETO UEKAMA
Keyword(s):  
Dosage Form ◽  
Oral Dosage ◽  
Modified Release ◽  
Oral Dosage Form

scholarly journals Statistical optimization of alginate-based oral dosage form of 5-aminosalicylic acid aimed to colonic delivery: In vitro and in vivo evaluation

2019 ◽  
Vol 52 ◽  
pp. 177-188 ◽  
Author(s):  
Ehsan Kaffash ◽  
Farinaz Saremnejad ◽  
Mohammadreza Abbaspour ◽  
Seyed Ahmad Mohajeri ◽  
Hadi Afrasiabi Garekani ◽  
...  
Keyword(s):  
Dosage Form ◽  
Statistical Optimization ◽  
Oral Dosage ◽  
Aminosalicylic Acid ◽  
Colonic Delivery ◽  
In Vivo Evaluation ◽  
Oral Dosage Form

scholarly journals Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities

2021 ◽  
Vol 24 ◽  
pp. 548-562
Author(s):  
Matthias Shona Roost ◽  
Henrike Potthast ◽  
Chantal Walther ◽  
Alfredo García-Arieta ◽  
Ivana Abalos ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
In Vitro Dissolution ◽  
Quantitative Composition ◽  
Modified Release ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less straightforward for modified release products than for immediate release products. There is consensus that modified release products should demonstrate bioequivalence not only in the fasted state but also in the fed state, but differences exist regarding the necessity of additional multiple dose studies. Fundamental differences between jurisdictions are revealed regarding requirements on the quantitative composition of different strengths and the differentiation of single and multiple unit dosage forms. Differences in terms of in vitro dissolution requirements are obvious, though these are mostly related to possible additional comparative investigations rather than regarding the need for product-specific methods. As with the requirements for immediate release products, harmonization of the various regulations for modified release products is highly desirable to conduct the appropriate studies from a scientific point of view, thus ensuring therapeutic equivalence.

Design and in vitro evaluation of a novel poly(methacrylic acid)/metronidazole antibacterial nanogel as an oral dosage form

2014 ◽  
Vol 118 ◽  
pp. 65-71 ◽  
Author(s):  
Tao Chen ◽  
Liang Chen ◽  
Haicheng Li ◽  
Yuhui Chen ◽  
Huixin Guo ◽  
...  
Keyword(s):  
Methacrylic Acid ◽  
Dosage Form ◽  
Oral Dosage ◽  
In Vitro Evaluation ◽  
Oral Dosage Form

In vivo efficacy of a novel double liposome as an oral dosage form of salmon calcitonin

2003 ◽  
Vol 58 (3) ◽  
pp. 253-257 ◽  
Author(s):  
Yoshinori Ebato ◽  
Yoshinori Kato ◽  
Hiraku Onishi ◽  
Tsuneji Nagai ◽  
Yoshiharu Machida
Keyword(s):  
Salmon Calcitonin ◽  
Dosage Form ◽  
Oral Dosage ◽  
In Vivo Efficacy ◽  
Oral Dosage Form

scholarly journals Future outlook hydrodynamic drug delivery system of solid oral dosage form: Review

2021 ◽  
Vol 6 (3) ◽  
pp. 96-101
Author(s):  
Akhilesh Kumar Singh ◽  
Neeraj Sharma
Keyword(s):  
Drug Delivery ◽  
Therapeutic Efficacy ◽  
Dosage Form ◽  
In Vitro Study ◽  
Local Effect ◽  
Oral Dosage ◽  
In Vivo Evaluation ◽  
Absorption Window

Over the last few years, therapeutic efficacy of drugs that have poor bioavailability or narrow absorption window have challenged the pharmaceutical industry. In this framework, many Hydrodynamic Balance System (HBS) also known as Gastro retentive dosage forms (GRDFs) have been used to enhance the therapeutic efficacy of drugs. Such drug have a narrow absorption window, are unstable at higher pH, are soluble in acidic conditions, and are local effect in the gastric-part. The drug development with recent technology of various novel polymeric-based gastroretentive drug delivery technologies that may regulate the bioavailability and extend time of therapeutic efficacy of such drugs. Our focus on the significance of in vitro study and in vivo evaluation parameters of various HBS drugs along with their applications.  This study provides a promising platform for advantages and guide formulation of HBS dosage form were covered in detail.

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