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Papers by MONIKA KHARB
Journal of Pharmaceutical Research International, 2022
Introduction: The traditional development processes use a quality by testing (QbT) approach that ... more Introduction: The traditional development processes use a quality by testing (QbT) approach that needs continuous testing to determine quality. Such processes are fixed, averse to change, and focus only on process reproducibility. This approach does not allow variation in material and process controls. In order to overcome the shortcomings of the traditional process, regulatory bodies have issued guidelines for the industries to improve the understanding of the process and the quality of the product. It aims to shift from traditional process QbT to a scientific approach quality by design (QbD) to assure product quality in the pharmaceutical industry. Methodology: Articles related to QbD published in many search engines such as Scopus, Google Scholar, and PubMed were reviewed. Review Findings: In order to ensure the quality of pharmaceutical products, regulatory bodies have emphasized on the implementation of QbD. For this, various guidelines have been published from time to time. Th...
International Journal of Applied Pharmaceutics, 2021
Objective: The aim of this study is to develop a gastroretentive microsphere of pregabalin using ... more Objective: The aim of this study is to develop a gastroretentive microsphere of pregabalin using design of experiment (DoE) to decrease dosing frequency and increasing bioavailability. Methods: Pregabalin microsphere was prepared by W/O/O multiple emulsion method using a mixture of ethyl cellulose (EC) and polyvinyl pyrrolidone (PVP) as rate-controlling polymer. Mixed solvent system comprising of dichloromethane (DCM) and acetonitrile (ACN) and light liquid paraffin was chosen as primary and secondary oil phase respectively. Taguchi design was employed for factor screening and Box Behnken design was used for the optimisation of critical process parameters. Results: Taguchi design revealed that polymer: drug, DCM: ACN and PVP: EC is the critical factor for the preparation of microspheres. The optimized formulation was prepared using polymer: drug (4.95:1), DCM: ACN (53.76: 46.24) and PVP: EC (2:5) which showed mean particle size of 203.34±4.82 µm, practical yield of 87.52±2.91 %, enc...
International Journal of Applied Pharmaceutics, May 7, 2021
The aim of this study is to develop a gastroretentive microsphere of pregabalin using design of e... more The aim of this study is to develop a gastroretentive microsphere of pregabalin using design of experiment (DoE) to decrease dosing frequency and increasing bioavailability. Methods: Pregabalin microsphere was prepared by W/O/O multiple emulsion method using a mixture of ethyl cellulose (EC) and polyvinyl pyrrolidone (PVP) as rate-controlling polymer. Mixed solvent system comprising of dichloromethane (DCM) and acetonitrile (ACN) and light liquid paraffin was chosen as primary and secondary oil phase respectively. Taguchi design was employed for factor screening and Box Behnken design was used for the optimisation of critical process parameters. Results: Taguchi design revealed that polymer: drug, DCM: ACN and PVP: EC is the critical factor for the preparation of microspheres. The optimized formulation was prepared using polymer: drug (4.95:1), DCM: ACN (53.76: 46.24) and PVP: EC (2:5) which showed mean particle size of 203.34±4.82 µm, practical yield of 87.52±2.91 %, encapsulation efficiency of 96.43±3.14 %, floating ability up to 90.42±1.64 % and T60% of 332.81±5.84. Drug release from microsphere followed Higuchi Kinetic model. Conclusion: In a nutshell, microspheres with excellent flowability and great encapsulation efficiency were successfully developed. These can be useful in improving patient compliance by reducing frequent dosing.
Journal of Pharmaceutical Research International, 2022
Introduction: The traditional development processes use a quality by testing (QbT) approach that ... more Introduction: The traditional development processes use a quality by testing (QbT) approach that needs continuous testing to determine quality. Such processes are fixed, averse to change, and focus only on process reproducibility. This approach does not allow variation in material and process controls. In order to overcome the shortcomings of the traditional process, regulatory bodies have issued guidelines for the industries to improve the understanding of the process and the quality of the product. It aims to shift from traditional process QbT to a scientific approach quality by design (QbD) to assure product quality in the pharmaceutical industry. Methodology: Articles related to QbD published in many search engines such as Scopus, Google Scholar, and PubMed were reviewed. Review Findings: In order to ensure the quality of pharmaceutical products, regulatory bodies have emphasized on the implementation of QbD. For this, various guidelines have been published from time to time. Th...
International Journal of Applied Pharmaceutics, 2021
Objective: The aim of this study is to develop a gastroretentive microsphere of pregabalin using ... more Objective: The aim of this study is to develop a gastroretentive microsphere of pregabalin using design of experiment (DoE) to decrease dosing frequency and increasing bioavailability. Methods: Pregabalin microsphere was prepared by W/O/O multiple emulsion method using a mixture of ethyl cellulose (EC) and polyvinyl pyrrolidone (PVP) as rate-controlling polymer. Mixed solvent system comprising of dichloromethane (DCM) and acetonitrile (ACN) and light liquid paraffin was chosen as primary and secondary oil phase respectively. Taguchi design was employed for factor screening and Box Behnken design was used for the optimisation of critical process parameters. Results: Taguchi design revealed that polymer: drug, DCM: ACN and PVP: EC is the critical factor for the preparation of microspheres. The optimized formulation was prepared using polymer: drug (4.95:1), DCM: ACN (53.76: 46.24) and PVP: EC (2:5) which showed mean particle size of 203.34±4.82 µm, practical yield of 87.52±2.91 %, enc...
International Journal of Applied Pharmaceutics, May 7, 2021
The aim of this study is to develop a gastroretentive microsphere of pregabalin using design of e... more The aim of this study is to develop a gastroretentive microsphere of pregabalin using design of experiment (DoE) to decrease dosing frequency and increasing bioavailability. Methods: Pregabalin microsphere was prepared by W/O/O multiple emulsion method using a mixture of ethyl cellulose (EC) and polyvinyl pyrrolidone (PVP) as rate-controlling polymer. Mixed solvent system comprising of dichloromethane (DCM) and acetonitrile (ACN) and light liquid paraffin was chosen as primary and secondary oil phase respectively. Taguchi design was employed for factor screening and Box Behnken design was used for the optimisation of critical process parameters. Results: Taguchi design revealed that polymer: drug, DCM: ACN and PVP: EC is the critical factor for the preparation of microspheres. The optimized formulation was prepared using polymer: drug (4.95:1), DCM: ACN (53.76: 46.24) and PVP: EC (2:5) which showed mean particle size of 203.34±4.82 µm, practical yield of 87.52±2.91 %, encapsulation efficiency of 96.43±3.14 %, floating ability up to 90.42±1.64 % and T60% of 332.81±5.84. Drug release from microsphere followed Higuchi Kinetic model. Conclusion: In a nutshell, microspheres with excellent flowability and great encapsulation efficiency were successfully developed. These can be useful in improving patient compliance by reducing frequent dosing.