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Shrestha, Sangam
- Application of Design of Experiments for Optimizing Critical Quality Attributes (CQA) in Routine Pharmaceutical Product Development
Abstract Views :206 |
PDF Views:120
Authors
Affiliations
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
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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- Basalious EB, El-Sebaie W, El-Gazayerly O. Application of pharmaceutical QbD for enhancement of the solubility and dissolution of a class II BCS drug using polymeric surfactants and crystallization inhibitors: development of controlled-release tablets. AAPS Pharmscitech. 2011;12(3):799-810.
- Lourenço V, Lochmann D, Reich G, Menezes JC, Herdling T, Schewitz J.A quality by design study applied to an industrial pharmaceutical fluid bed granulation. European J. Pharmaceutics and Biopharmaceutics. 2012;81(2):438-47.
- Chowdary KP, Shankar KR, Kumar PS. Recent research on QbD approach in formulation development:A review. Int.J.Chem.Sci.& Tech.2014;4(1):282-92.
- Ranga S, Jaimini M, Sharma SK, Chauhan BS, Kumar A. A review on Design of Experiments (DOE). Int. J. Pharm. Chem.Sci.2014;3(1):216-24.
- Jain S. Quality by design (QBD): a comprehen-sive understanding of implementation and challenges in pharmaceuticals development. Int. J. Pharm. Pharm. Sci.2014; 6:29-35.
- Telford JK.A brief introduction to design of experiments. Johns Hopkins apl technical digest.2007 Sep;27(3):224-32.
- Simpson TW, Peplinski J, Koch PN, Allen JK.On the use of statistics in design and the implications for deterministic computer experiments. Design Theory and Methodo-logy-DTM'97.1997;Sep 14:14-7.
- Garg RK, Singhvi I. Optimization Techniques: An Overview For Formulation Development.Asian J.Pharm. Res.Vol.2015;5(3):217-21.
- Raman NV, Mallu UR, Bapatu HR. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. Journal of Chemistry.2015 Jan 26;2015.
- Bhoop BS. Quality by Design (QbD) for holistic pharma excellence and regulatory compliance. Pharm Times. 2014;46(8):26-33
- Assessment of Climate Change Impact on Water Diversion from the Bago River to the Moeyingyi Wetland, Myanmar
Abstract Views :217 |
PDF Views:110
Authors
Affiliations
1 Water Engineering and Management, School of Engineering and Technology, Asian Institute of Technology, Pathum Thani 12120, TH
2 Agricultural Systems and Engineering, School of Environment, Resources and Development, Asian Institute of Technology, Pathum Thani 12120,, TH
1 Water Engineering and Management, School of Engineering and Technology, Asian Institute of Technology, Pathum Thani 12120, TH
2 Agricultural Systems and Engineering, School of Environment, Resources and Development, Asian Institute of Technology, Pathum Thani 12120,, TH
Source
Current Science, Vol 112, No 02 (2017), Pagination: 377-384Abstract
Originally built for flood control, the Moeyingyi wetland, Myanmar now provides valuable resources such as fishery, irrigation water and tourism, and is also home to many rare species and migratory birds. This is the only wetland in Myanmar listed as a Ramsar Site. Bias-corrected climate data from three general circulation models under two emission scenarios of IPCC Assessment Report 5 (AR5), namely RCP 4.5 and RCP 8.5 were used to forecast temperature and rainfall. Future climate scenarios were predicted for three future periods as 2020s (2021-30), 2030s (2031- 40) and 2040s (2041-50). The Soil Water Assessment Tool (SWAT) was used for hydrological analysis to predict water availability. Analysis suggests that the discharge is expected to decrease during dry season, which can have a negative impact on the diversion of water from the Bago River to the Moeyingyi wetland. On the other hand, discharge is likely to increase during July and can further worsen the recurring floods. Similarly, inflow at the Moeyingyi wetland is expected to decrease in future. Hence, robust adaptation strategies should be formulated to cope with the negative impact of climate change.Keywords
Climate Change, Hydrological Analysis, Water Diversion, Wetlands.Full Text
- A Review:Solid Dispersion, a Technique of Solubility Enhancement
Abstract Views :330 |
PDF Views:101
Authors
Affiliations
1 Krupanidhi College of Pharmacy, Chikkabellandur Village, Carmelaram Post, Varthur Hobli, Bangalore - 560035, IN
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
References
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- Ankit M, Manish Y, Dinesh C. Solid dispersion: A technique to improve solubility of poorly water soluble drug. Indo Am J Pharm Res. 2014;4(6): 2855-2866.
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- Dixit AK, Singh RP, Singh S. Solid dispersion-a strategy for improving the solubility of poorly soluble drugs. Int J Res Pharm Biomed Sci. 2012;3(2): 960-966.
- Yadav PS, Kumar V, Singh UP, Bhat HR, Mazumder B. Physicochemical characterization and in vitro dissolution studies of solid dispersions of ketoprofen with PVP K30 and D-mannitol. Saudi Pharm J. 2013;21(1): 77-84.
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- Sridhar I, Doshi A, Joshi B, Wankhede V, Doshi J. Solid dispersions: an approach to enhance solubility of poorly water soluble drug. J Sci Innov Res. 2013;2(3): 685-694.
- Projection of Climate Change Scenarios in the Kabul River Basin, Afghanistan
Abstract Views :198 |
PDF Views:72
Authors
Affiliations
1 Department of Civil and Infrastructure Engineering, School of Engineering and Technology, Asian Institute of Technology, Pathum Thani 12120, TH
2 Department of Information and Communication Technologies, School of Engineering and Technology, Asian Institute of Technology, Pathum Thani 12120, TH
1 Department of Civil and Infrastructure Engineering, School of Engineering and Technology, Asian Institute of Technology, Pathum Thani 12120, TH
2 Department of Information and Communication Technologies, School of Engineering and Technology, Asian Institute of Technology, Pathum Thani 12120, TH
Source
Current Science, Vol 114, No 06 (2018), Pagination: 1304-1310Abstract
This study was conducted to examine the changes in future temperature and precipitation of the Kabul River Basin in Afghanistan by using the outputs of three general circulation models (GCMs) under two representative concentration pathway (RCP 4.5 and RCP 8.5) scenarios. Future climate data for temperature and precipitation obtained from climate models were bias corrected using the delta change approach. Maximum and minimum temperatures and precipitation were projected for three future periods: 2020s, 2050s and 2080s against the baseline period of 1961–1980. The mean annual temperature in the basin is projected to increase by 1.8°C, 3.5°C and 4.8°C by the 2020s, 2050s and 2080s respectively. The mean annual precipitation is projected to increase whereas monthly precipitation is expected to increase and decrease according to the months for the whole river basin, under both scenarios, by 2100.Keywords
Climate Change, Kabul River Basin, RCPs, Temperature, Precipitation.Full Text
References
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- Projections of Extreme Precipitation Events under Climate Change Scenarios in Mahaweli River Basin of Sri Lanka
Abstract Views :274 |
PDF Views:111
Authors
Affiliations
1 Department of Civil and Infrastructure Engineering, School of Engineering and Technology, Asian Institute of Technology, Pathum Thani 12120, TH
2 Department of Food, Agriculture and Bioresources, School of Environment Resources and Development, Asian Institute of Technology, Pathum Thani 12120, TH
1 Department of Civil and Infrastructure Engineering, School of Engineering and Technology, Asian Institute of Technology, Pathum Thani 12120, TH
2 Department of Food, Agriculture and Bioresources, School of Environment Resources and Development, Asian Institute of Technology, Pathum Thani 12120, TH
Source
Current Science, Vol 114, No 07 (2018), Pagination: 1495-1509Abstract
The future changes in rainfall pattern in the Mahaweli River Basin of Sri Lanka using three general circulation models under two representative concentration pathways were assessed. The projections showed that consecutive dry days will decrease, consecutive wet days and annual total precipitation in wet days will increase, the monthly maximum consecutive five-day precipitation will generally decrease, and annual rainfall will increase except for the first inter-monsoon. The projections of the heavy rainfall varied according to the time periods and climate zones. The present results can help policy makers to optimize the use of water resources considering future climate change.Keywords
Bias Correction, Climate Change, Extreme Precipitation, GCMs, Rainfall, RCPs.Full Text
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