A B C D E F G H I J K L M N O P Q R S T U V W X Y Z All
Soans, Deborose
- 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.Full Text
References
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- Enhancing the Solubility of BCS Class II and IV Drugs by Sedds Approach-A Structured Review
Authors
1 Krupanidhi College of Pharmacy, Chikka Bellandur, Carmelaram Post, Varthur Hobli, Bangalore-560035, IN
Source
Journal of Pharmaceutical Research, Vol 15, No 4 (2016), Pagination: 174-180Abstract
Purpose: The solubility of orally administered hydrophobic drugs ismajor challenge for pharmaceutical formulators as nearly 35-40% of newly launched drugs possess low aqueous solubility which leads to poor dissolution and low bioavailability, resulting in high intra&inter subject variability&lack of dose proportionality.
Approach: Self-Emulsifying Drug Delivery System, (SEDDS) is gaining popularity for improving the solubility of lipophilic drugs. Therefore, various formulation strategies have been investigated to improve the solubility and the rate of dissolution to enhance the oral bioavailability of lipophilic drugs.
Finding: This review mainly discusses about the mechanism of SEDDS, excipient used in SEEDS, dosage forms, evaluation, applications, advantages and drawbacks.
Conclusion: SEDDS form fine emulsions (or micro-emulsions) in gastro-intestinal tract (GIT) with mild agitation provided by gastric mobility. Many parameters like surfactant concentration, oil/surfactant ratio, polarity of the emulsion, droplet size and charge plays a critical role in oral absorption of drug from SEEDS.
Keywords
SEDDS, Hydrophobic Drugs, Micro Emulsion, Lipid Based System.Full Text
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.Full Text
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