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Home/ All Articles/ Formulation Development, Analytical Validation and In vitro Assessment of a Generic Lymecy…

Abstract & Article Details

Research Article • Vol.7, Issue 3 • ISSN: 2766-2276 • Open Access • CC BY 4.0

Open Access Research Article Vol.7, Issue 3 March 9, 2026

Formulation Development, Analytical Validation and In vitro Assessment of a Generic Lymecycline 408 mg Hard Capsule

DOI: 10.37871/jbres2278
Authors
Ali Raza, Noor Zulfi qar*, Yameen HM, Fatima A, Rizwan M, Mahmood I, Ain QU and Imran M

Abstract

This study documents the stepwise development and evaluation of a generic Lymecycline 408 mg hard gelatin capsule manufactured locally in Pakistan. The formulation process began with the selection of suitable pharmacopeial excipients after conducting accelerated compatibility testing to ensure that no undesirable physical or chemical interactions occurred with the active ingredient. Based on these preliminary investigations, a stable capsule composition was finalized. The finished capsules were evaluated according to British Pharmacopoeia requirements. All tested quality attributes, including assay, dissolution behavior, content uniformity, and moisture content, were found to comply with the specified limits. These results confirmed the consistency and integrity of the developed dosage form. Quantitative analysis of Lymecycline was carried out using a high-performance liquid chromatography method that was validated prior to routine application. During validation, parameters such as specificity, precision under repeat and intermediate conditions, accuracy through recovery assessment, robustness against minor variations, and system suitability were carefully examined. The method demonstrated reliable and reproducible performance in line with internationally accepted regulatory standards. To assess comparative in-vitro performance, dissolution testing was performed using the USP paddle method in media representing gastric and intestinal pH conditions (pH 1.2, 4.5, and 6.8). In all cases, more than 85% of the drug was released within one hour. Statistical comparison with the reference product, Tetralysal® 300 mg, showed acceptable similarity and difference factor values, indicating comparable release profiles. Overall, the data support that the developed formulation performs equivalently to the reference product and may be considered suitable for local production and further regulatory processing.

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How to Cite

Ali Raza, Noor Zulfi qar*, Yameen HM, Fatima A, Rizwan M, Mahmood I, Ain QU and Imran M (2026). Formulation Development, Analytical Validation and In vitro Assessment of a Generic Lymecycline 408 mg Hard Capsule. Journal of Biomedical Research & Environmental Sciences, 7(3). https://doi.org/10.37871/jbres2278

Article Information

JournalJournal of Biomedical Research & Environmental Sciences (JBRES)
ISSN2766-2276
DOI DOI 10.37871/jbres2278
Volume / IssueVol. 7, Issue 3
ReceivedFebruary 17, 2026
AcceptedMarch 6, 2026
PublishedMarch 9, 2026
Article TypeResearch Article
Pages1-20
LicenseCC BY 4.0 — Open Access
PublisherSciRes Literature LLC, Sheridan, WY, USA
LanguageEnglish
Creative Commons BY 4.0

Published under CC BY 4.0 — free to share, copy, adapt, and redistribute with attribution.

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