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Published on:October 2020
Indian Journal of Pharmaceutical Education and Research, 2020; 54(3s):s473-s484
Original Article | doi:10.5530/ijper.54.3s.146

Solid Dosage Forms: A Detailed Research on Non-conforming Product Quality


Authors and affiliation (s):

Katta Hemanth G1, Ravindra Shenoy U2, Girish Thunga3, Sudeep Kumar Agrawal4, Mahendra Joshi5, Muddukrishna Badamane Sathyanarayana6, Vamshi Krishna Tippavajhala1, Abhinaya N1, Girish Pai Kulyadi1,*

1Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, INDIA.

2Department of Commerce, Manipal Academy of Higher Education, Manipal, Karnataka, INDIA.

3Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, INDIA.

4Product Development, Sun Pharmaceutical Industries Ltd., Vadodara, Gujarat, INDIA.

5Research and Development, IDRS Labs Pvt. Ltd., Bangalore, Karnataka, INDIA.

6Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, INDIA.

Abstract:

Introduction: Any defects in pharmaceutical products lead to minor, major, or critical deviation and if such a product is released, it also leads to product recalls and legal actions. In such cases, the concern is about patient’s safety rather than the company’s economy and fame. This study aimed to investigate the various quality defects which have occurred in marketed tablets. Materials and Methods: The investigation was carried out which involved identification of defects, categorizing the type, root causes, suggesting remedial measures and documenting the clinical significance of defective dosage forms of tablets. Dosage forms included were film-coated tablets, uncoated tablets, uncoated caplet shaped tablets and dispersible tablets which are prescribed for their specific therapeutic activity. Results: This research work has revealed quality issues of minor, major and critical types. These defects were unique in nature and appeared to be stray incidents which were not available even in standard textbooks or literature. Conclusion: Medicines being the silver sword to treat an ailment in a patient, it should not involve any quality issues leading to a significant impact on the safety and efficacy of the prescribed drug. It is essential to embed an attentive and dedicated quality assurance (QA) team and adhere to all the regulations laid by regulatory agencies in the pharmaceutical setup thereby ensuring that high-quality medicines are supplied and the safety of the patient is shielded.

Key words: Tablets, Solid dosage forms, Tablet defects, Patient perception, Investigation, Quality Assurance.

 




 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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