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Shrestha, Sangam
- Application of Design of Experiments for Optimizing Critical Quality Attributes (CQA) in Routine Pharmaceutical Product Development
Authors
1 Department of Quality Assurance, Krupanidhi College of Pharmacy, Chikkabellandur Village, Carmelaram Post, Varthur Hobli, Bangalore - 560035, IN
2 Department of Pharmaceutics, Krupanidhi College of Pharmacy, Chikkabellandur Village, Carmelaram Post, Varthur Hobli, Bangalore - 560035, IN
Source
Journal of Pharmaceutical Research, Vol 15, No 3 (2016), Pagination: 96-100Abstract
Purpose: QbD is a helpful tool in building quality products and to understand critical process parameters which affects the manufacturing of drug products. It helps to build control strategy which helps to maintain quality throughout its life cycle.
Approaches: The major approach in QbD is through DOE which includes either screening or optimization done by various designs like plackett-Burmann, Box-Behnken design, Fractional Factorial design, Central Composite design, Mixture design etc.
Findings: QbD approach helps in formulating and maintaining quality in the drug product. It helps to identify the critical quality attributes and process parameters which are likely to affect the quality of the drug product through screening design.
Conclusions: Adopting QbD concepts into manufacturing of the drug product has its advantage of reducing development and marketing costs. It also helps in meeting regulatory requirements.
Keywords
QbD, DOE, Process Optimization, QTPP, CQA.References
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- A Review:Solid Dispersion, a Technique of Solubility Enhancement
Authors
1 Krupanidhi College of Pharmacy, Chikkabellandur Village, Carmelaram Post, Varthur Hobli, Bangalore - 560035, IN
Source
Journal of Pharmaceutical Research, Vol 16, No 1 (2017), Pagination: 25-31Abstract
Purpose: The aim of the study was to explore the necessity, advantages and different techniques of solid dispersion for enhancing solubility of poorly soluble drugs.
Approach: Different types of solid dispersion have been explained briefly along with the various techniques of solid dispersion in detail.
Findings: Solid dispersions of poorly soluble drugs have been found to give positive results in enhancing its solubility and dissolution characters.
Conclusion: Solid dispersion techniques improve solubility and bioavailability of poorly soluble drugs. Solid dispersions can be incorporated into various dosage forms with wide range of applicability.
Keywords
Solid Dispersion Techniques, Solubility, Advantages, Disadvantages, Carriers.References
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