Application of quality by design principles for optimizing process variables of Extrusion and Spheronization of a Captopril Pellet Formulation:
- Veerubhotla, Krishna, Walker, Roderick B
- Authors: Veerubhotla, Krishna , Walker, Roderick B
- Date: 2020
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/178312 , vital:40098 , DOI: 10.36468/pharmaceutical-sciences.624
- Description: Product development using quality by design is a proactive and risk-based approach that shifts the manufacturing process from empirical to science-based. Risk assessment was performed to identify and analyse risk areas for the manufacture of captopril pellets. Twelve experimental runs were performed using a Plackett-Burman screening design. Pareto plots revealed the effect of formulation and process variables on the responses monitored and facilitated the identification of the most critical parameters for optimization of the formulation. A response surface methodology approach in conjunction with a central composite design was used to optimize the Eudragit® RL 30D (15-30 ml), microcrystalline cellulose (20-40 % w/w), sodium starch glycolate (2-5 % w/w) and spheronizer speed (650-1050 rpm).
- Full Text:
- Date Issued: 2020
- Authors: Veerubhotla, Krishna , Walker, Roderick B
- Date: 2020
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/178312 , vital:40098 , DOI: 10.36468/pharmaceutical-sciences.624
- Description: Product development using quality by design is a proactive and risk-based approach that shifts the manufacturing process from empirical to science-based. Risk assessment was performed to identify and analyse risk areas for the manufacture of captopril pellets. Twelve experimental runs were performed using a Plackett-Burman screening design. Pareto plots revealed the effect of formulation and process variables on the responses monitored and facilitated the identification of the most critical parameters for optimization of the formulation. A response surface methodology approach in conjunction with a central composite design was used to optimize the Eudragit® RL 30D (15-30 ml), microcrystalline cellulose (20-40 % w/w), sodium starch glycolate (2-5 % w/w) and spheronizer speed (650-1050 rpm).
- Full Text:
- Date Issued: 2020
The use of response surface methodology to evaluate the impact of level 2 SUPAC–IR changes on the in vitro release of metronidazole and ranitidine from a fixed-dose combination tablet
- King’ori, Loti D, Walker, Roderick B
- Authors: King’ori, Loti D , Walker, Roderick B
- Date: 2012
- Language: English
- Type: text , Article
- Identifier: vital:6391 , http://hdl.handle.net/10962/d1006313
- Description: The purpose of this study was to evaluate the effect of different levels of disintegrant (croscarmellose sodium, CCS), binder (polyvinylprrolidone K30, PVP–K30), and lubricant (magnesium stearate) on the in vitro release of metronidazole (MTZ) and rantidine (RTD) from a solid oral fixed-dose combination tablet. The excipient levels investigated were Level 2 changes in component and composition described in the Scale-Up and Post Approval Changes for Immediate Release (SUPAC–IR) guidance (1). Batches of tablets (1000 units) were manufactured by wet granulation using a Saral high-shear mixer granulator and a Manesty B3B rotary tablet press. Weight uniformity, friability, and disintegration of all tablets were assessed, and all batches complied with compendial specifications. The amount of drug released (Q) at ten minutes was dependent on the levels of CCS in the formulation, and the effect of PVP–K30 and magnesium stearate was dependent on the levels of CCS. Synergistic interactions between independent variables were observed for the Q10 value for RTD, whereas PVP–K30 and magnesium stearate exhibited an antagonistic effect on the Q10 values for MTZ and RTD. The use of response surface methodology facilitated an investigation into the effect of Level 2 component and composition changes, as described in SUPAC–IR, on the in vitro release of MTZ and RTD from a fixed-dose combination (FDC) solid oral dosage form (SODF).
- Full Text:
- Date Issued: 2012
- Authors: King’ori, Loti D , Walker, Roderick B
- Date: 2012
- Language: English
- Type: text , Article
- Identifier: vital:6391 , http://hdl.handle.net/10962/d1006313
- Description: The purpose of this study was to evaluate the effect of different levels of disintegrant (croscarmellose sodium, CCS), binder (polyvinylprrolidone K30, PVP–K30), and lubricant (magnesium stearate) on the in vitro release of metronidazole (MTZ) and rantidine (RTD) from a solid oral fixed-dose combination tablet. The excipient levels investigated were Level 2 changes in component and composition described in the Scale-Up and Post Approval Changes for Immediate Release (SUPAC–IR) guidance (1). Batches of tablets (1000 units) were manufactured by wet granulation using a Saral high-shear mixer granulator and a Manesty B3B rotary tablet press. Weight uniformity, friability, and disintegration of all tablets were assessed, and all batches complied with compendial specifications. The amount of drug released (Q) at ten minutes was dependent on the levels of CCS in the formulation, and the effect of PVP–K30 and magnesium stearate was dependent on the levels of CCS. Synergistic interactions between independent variables were observed for the Q10 value for RTD, whereas PVP–K30 and magnesium stearate exhibited an antagonistic effect on the Q10 values for MTZ and RTD. The use of response surface methodology facilitated an investigation into the effect of Level 2 component and composition changes, as described in SUPAC–IR, on the in vitro release of MTZ and RTD from a fixed-dose combination (FDC) solid oral dosage form (SODF).
- Full Text:
- Date Issued: 2012
Should active recruitment of health workers from sub-Saharan Africa be viewed as a crime?
- Mills, E J, Schabas, W A, Volmink, J, Walker, Roderick B, Ford, N, Katabira, E, Anema, A, Joffres, M, Cahn, P, Montaner, J
- Authors: Mills, E J , Schabas, W A , Volmink, J , Walker, Roderick B , Ford, N , Katabira, E , Anema, A , Joffres, M , Cahn, P , Montaner, J
- Date: 2008
- Language: English
- Type: Article
- Identifier: vital:6392 , http://hdl.handle.net/10962/d1006314
- Description: (Conclusion) When the international community permits for-profit companies to actively entice overworked and often underpaid workers away from the most vulnerable populations, it is contributing to the deterioration of essential health-care delivery. Improvement of the health of the world’s poor is a challenge that the international community is failing to adequately address. Current international treaties and commitments are severely compromised if we are unwilling to adhere to their principles and prevent obvious harms to poor people. Clear, enforced regulation is needed to prevent recruitment companies from enticing health workers away from their local work, and developed countries should adequately compensate less-developed countries for the human resources they have lost and continue to lose.
- Full Text:
- Date Issued: 2008
- Authors: Mills, E J , Schabas, W A , Volmink, J , Walker, Roderick B , Ford, N , Katabira, E , Anema, A , Joffres, M , Cahn, P , Montaner, J
- Date: 2008
- Language: English
- Type: Article
- Identifier: vital:6392 , http://hdl.handle.net/10962/d1006314
- Description: (Conclusion) When the international community permits for-profit companies to actively entice overworked and often underpaid workers away from the most vulnerable populations, it is contributing to the deterioration of essential health-care delivery. Improvement of the health of the world’s poor is a challenge that the international community is failing to adequately address. Current international treaties and commitments are severely compromised if we are unwilling to adhere to their principles and prevent obvious harms to poor people. Clear, enforced regulation is needed to prevent recruitment companies from enticing health workers away from their local work, and developed countries should adequately compensate less-developed countries for the human resources they have lost and continue to lose.
- Full Text:
- Date Issued: 2008
Application of the Minolta chromameter to the assessment of corticosteroid-induced skin blanching
- Walker, Roderick B, Haigh, John M, Smith, Eric W
- Authors: Walker, Roderick B , Haigh, John M , Smith, Eric W
- Date: 2000
- Language: English
- Type: Book chapter , text
- Identifier: vital:6451 , http://hdl.handle.net/10962/d1006639
- Full Text:
- Date Issued: 2000
- Authors: Walker, Roderick B , Haigh, John M , Smith, Eric W
- Date: 2000
- Language: English
- Type: Book chapter , text
- Identifier: vital:6451 , http://hdl.handle.net/10962/d1006639
- Full Text:
- Date Issued: 2000
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