Journal: Drug Invention Today

Article Id: JPRS-P'ceu-00005042
Title: Holding time stability study of intermediates of core and coated tablets
Category: Pharmaceutics
Section: Research Article
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    Objective: The aim of the study was to evaluate the quality of intermediates stored at a temperature between 15°C and 25°C. Hold time stability study sets the time limit for keeping the products at different production stages. This guarantees that product quality during hold time does not yield results outside the acceptance criteria. The study design will represent the time of hold at each point. Materials and Methods: The experimental study was done using the antidiabetic drug on the initial day followed by 30 days and 90 days. Results and Discussion: Results of the hold time stability data of coated antidiabetic tablets 10 mg strength after 90 days reveal that the critical quality parameters mentioned are well within the specified limits when stored at a temperature between 15°C and 25°C in the manufacturing area. Conclusion: Critical quality attributes were not affected on holding and all the limits were within specification.

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    Author(s) Name:

    Safvana Fava, M. P. Gowrav*, S. Hemanth Kumar, H. V. Gangadharappa

    Affiliation(s) Name:

    Department of Pharmaceutics, Pharmaceutical Quality Assurance Group, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India

    *Corresponding author: M. P. Gowrav, Department of Pharmaceutics, Pharmaceutical Quality Assurance Group, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagar, Mysuru - 570 015, Karnataka, India.

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    Author:

    Safvana Fava, M. P. Gowrav*, S. Hemanth Kumar, H. V. Gangadharappa

    Title:Holding time stability study of intermediates of core and coated tablets
    Journal:Drug Invention Today
    Vol(issue):14 (May)
    Year:2020
    Page No: (772-775)
  • Experimental Methods Keywords

    Methodology:: Acceptance criteria, Critical quality attributes, Hold time stability study
    Research Materials:Antidiabetic drugs

Keywords

: Acceptance criteria Antidiabetic drugs Critical quality attributes Hold time stability study

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