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239165

A BRIEF REVIEW ON PHARMACEUTICAL DISSOLUTION INTERLINKING THE ASPECTS OF SCIENCE AND REGULATION

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Last updated: 04 Jan 2025

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Abstract

Dissolution is a multistep process describes the affinity of the solute and the solvent by which a solid substance interacts among the heterogeneous phases of solute -solute, solvent-solvent, and the solute-solvent interface to yield a solution. In the pharmaceutical industry dissolution testing of solid dosage form gives a signal of the operability of the dosage form in the biological system. The rate of absorption is partially or completely controlled by the dissolution of the drug from its dosage forms in the gastrointestinal tract. Dissolution, the vital quality control aspects, also ensure batch-to-batch uniformity in drug release, bioavailability, and the development of efficacious therapeutic dosage forms. It also ensures the evaluation of their critical biopharmaceutical parameters. Hence the study of dissolution is an interplay between the science and the development of the regulatory profile of a dosage form for quality control aspects. The present review focuses on the science, factors relevant to in-vitro dissolution, and therefore the role of its in pharmaceutical regulation.

DOI

10.21608/bfsa.2022.239165

Keywords

Dissolution, quality control, In-vitro in-vivo correlation, Hydrodynamic, Regulations

Authors

First Name

Biradar

Last Name

Gopal Rangarao

MiddleName

-

Affiliation

Department of Pharmaceutics, Krupanidhi College of Pharmacy, Bengaluru, India 560035

Email

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City

-

Orcid

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First Name

K

Last Name

Monica

MiddleName

-

Affiliation

Department of Pharmaceutics, Krupanidhi College of Pharmacy, Bengaluru, India 560035

Email

monica118.mk@gmail.com

City

-

Orcid

0000-0003-2407-3354

First Name

Sayani

Last Name

Bhattacharyya

MiddleName

-

Affiliation

Department of Pharmaceutics, Krupanidhi College of Pharmacy, Bengaluru, India 560035

Email

sayanibh@gmail.com

City

-

Orcid

0000-0002-4013-4316

Volume

45

Article Issue

1

Related Issue

34403

Issue Date

2022-06-01

Receive Date

2021-07-21

Publish Date

2022-06-01

Page Start

11

Page End

21

Print ISSN

1110-0052

Online ISSN

3009-7703

Article File

BFSA_Volume 45_Issue 1_Pages 11-21.pdf

PDF . 818.3kB

Link

https://bpsa.journals.ekb.eg/article_239165.html

Detail API

https://bpsa.journals.ekb.eg/service?article_code=239165

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2

Type

Original Article

Type Code

1,096

Publication Type

Journal

Publication Title

Bulletin of Pharmaceutical Sciences Assiut University

Publication Link

https://bpsa.journals.ekb.eg/

MainTitle

A BRIEF REVIEW ON PHARMACEUTICAL DISSOLUTION INTERLINKING THE ASPECTS OF SCIENCE AND REGULATION

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Article

Created At

22 Jan 2023