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Published on:July 2019
Indian Journal of Pharmaceutical Education and Research, 2019; 53(3):435-445
Original Article | doi:10.5530/ijper.53.3.76

Design of Experiments Approach to Discriminatory Dissolution Method Development of Poorly Soluble Drug in Immediate Release Dosage Form


Authors and affiliation (s):

Sudheer Babu Kolla1,2,*, Madhusudhan Rao Vallabhaneni1, Srinivasa Babu Puttagunta3, Maharshi Sudulagunta Venkata2

1Department of Chemistry, Vignan’s Foundation for Science, Technology and Research University, Vadlamudi, Guntur, Andhra Pradesh, INDIA.

2Department of Analytical Research and Development, Formulations, GVK Bio Sciences Pvt. Ltd, JP Nagar, Bangalore, Karnataka, INDIA.

3Department of Pharmacy, Vignan College of Pharmacy, Vadlamudi, Jawaharlal Nehru Technological University, Kakinada, Andhra Pradesh, INDIA.

Abstract:

Aim: The study involved design of experiment guided discriminatory dissolution method development for poorly soluble, ezetimibe tablets. Objective: In the current scope of study, ezetimibe tablets are selected as a suitable drug product candidate to evaluate the application of design of experiments in discriminatory dissolution method development for poorly soluble drug. Ezetimibe is practically insoluble in all the aqueous buffers. Methodology: 2-Level factorial design is selected as suitable model to build the experimental setup. Different factors like pH of dissolution media, sodium lauryl sulphate concentration, dissolution media volume and agitation speed (RPM) are selected for the study and dissolution % release at 5, 10, 15, 20, 45 min and % RSD of dissolution values at 20 min were selected as responses based on prior experience. The responses are evaluated for statistical significance and for adequacy of the built design with the help of different tools like ANOVA and diagnostic graphs. Results: It is observed that pH of dissolution media, surfactant concentration are having minimal positive effect on all of the responses. Whereas agitation speed and dissolution media volume were having significant positive effect on all responses, except for % RSD at 20 min and is inversely proportional to agitation speed. Conclusion: With the current scope of study design of experiments as an effective tool for discriminatory dissolution method development is employed to prove adequacy. Selected solutions from predictions were executed for experimental results and were compared against predictions to validate model.

Key words: DoE, Discriminatory dissolution method, Ezetimibe tablets, DoE aided dissolution method development.

 

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IJPER - An Official Publication of Association of Pharmaceutical Teachers of India is pleased to announce continued growth in the 2019 Release of Journal Citation Reports (source: 2018 Web of Science Data).

 

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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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