Formulation Development and In-vitro Characterization of Extended Release Venlafaxine HCl Pellets

  • Unique Paper ID: 183904
  • Volume: 12
  • Issue: 3
  • PageNo: 4141-4154
  • Abstract:
  • This study aimed to develop and characterize extended-release (ER) pellets of Venlafaxine Hydrochloride (HCl), an antidepressant, to achieve prolonged therapeutic action compared to immediate-release formulations, with pharmaceutical equivalence to the innovator product, Effexor XR®. The formulation process utilized the Wurster fluid bed coating technique, incorporating ethyl cellulose and medium-chain triglycerides as key excipients to control drug release. Preformulation studies confirmed the compatibility of Venlafaxine HCl with excipients through physical and analytical assessments. Seven trial formulations were prepared, with formulations T6 and T7 optimized based on evaluation parameters, including percentage yield, bulk density, loss on drying, water content, and drug content. In vitro dissolution studies demonstrated that T6 and T7 achieved 88–92% drug release over 20 hours, following first-order kinetics and the Higuchi matrix model, indicative of a super case II transport mechanism. The similarity factor (f2) ranged from 69 to 77, confirming equivalence to Effexor XR®. Stability studies, conducted per ICH guidelines under accelerated (40±2°C/75±5% RH) and long-term (25±2°C/60±5% RH) conditions for 30 and 90 days, respectively, revealed no significant changes in physicochemical properties. The optimized formulations (T6 and T7) effectively minimized dose dumping and provided a release profile suitable for once-daily administration, offering a viable generic alternative to Effexor XR®.

Copyright & License

Copyright © 2025 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BibTeX

@article{183904,
        author = {Dr. Devinder Maheshwari and Rajkumar},
        title = {Formulation Development and In-vitro Characterization of Extended Release Venlafaxine HCl Pellets},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {3},
        pages = {4141-4154},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=183904},
        abstract = {This study aimed to develop and characterize extended-release (ER) pellets of Venlafaxine Hydrochloride (HCl), an antidepressant, to achieve prolonged therapeutic action compared to immediate-release formulations, with pharmaceutical equivalence to the innovator product, Effexor XR®. The formulation process utilized the Wurster fluid bed coating technique, incorporating ethyl cellulose and medium-chain triglycerides as key excipients to control drug release. Preformulation studies confirmed the compatibility of Venlafaxine HCl with excipients through physical and analytical assessments. Seven trial formulations were prepared, with formulations T6 and T7 optimized based on evaluation parameters, including percentage yield, bulk density, loss on drying, water content, and drug content. In vitro dissolution studies demonstrated that T6 and T7 achieved 88–92% drug release over 20 hours, following first-order kinetics and the Higuchi matrix model, indicative of a super case II transport mechanism. The similarity factor (f2) ranged from 69 to 77, confirming equivalence to Effexor XR®. Stability studies, conducted per ICH guidelines under accelerated (40±2°C/75±5% RH) and long-term (25±2°C/60±5% RH) conditions for 30 and 90 days, respectively, revealed no significant changes in physicochemical properties. The optimized formulations (T6 and T7) effectively minimized dose dumping and provided a release profile suitable for once-daily administration, offering a viable generic alternative to Effexor XR®.},
        keywords = {Venlafaxine Hydrochloride, extended-release pellets, fluid bed coating, ethyl cellulose, medium-chain triglycerides, dissolution, release kinetics, stability, pharmaceutical equivalence, Effexor XR®},
        month = {September},
        }

Cite This Article

  • ISSN: 2349-6002
  • Volume: 12
  • Issue: 3
  • PageNo: 4141-4154

Formulation Development and In-vitro Characterization of Extended Release Venlafaxine HCl Pellets

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