Jonas Buck1,2, Jörg Huwyler2, Peter Kühl3, Angela Dischinger1. 1. Pharmaceutical Research and Development, F. Hoffmann-La Roche, Grenzacherstr. 124, CH-4070, Basel, Switzerland. 2. Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland. 3. Pharmaceutical Research and Development, F. Hoffmann-La Roche, Grenzacherstr. 124, CH-4070, Basel, Switzerland. peter.kuehl@roche.com.
Abstract
PURPOSE: The design of pediatric formulations is challenging. Solid dosage forms for children have to meet the needs of different ages, e.g. high number of dosing increments and strengths. A modular formulation strategy offering the possibility of rapid prototyping was applied. Different tablet compositions and the resulting tablet characteristics were investigated for dispersible tablets using customized analytical methods. METHODS: Fluid bed granules were blended with extragranular components, and compressed to tablets. Disintegration behavior was studied with a Texture Analyzer and a Tensiometer. RESULTS: Methods for determination of disintegration time and water uptake of tablets were developed with a Texture Analyzer, and a Tensiometer, respectively. Twenty-two different tablet formulations were prepared and analyzed with respect to disintegration time, hardness, friability, and viscosity. Multivariate data analysis revealed a high impact of type and amount of viscosity enhancer on the disintegration behavior of tablets. An optimized formulation was selected with a disintegration time of 24 s. CONCLUSION: Methods providing additional information on the disintegration behavior of dispersible tablets compared to standard pharmacopoeia methods were established. Selecting the right type and level of viscosity enhancer and superdisintegrant was critical for developing pediatric tablets with a disintegration time of less than 30 s but still pleasant mouth feel.
PURPOSE: The design of pediatric formulations is challenging. Solid dosage forms for children have to meet the needs of different ages, e.g. high number of dosing increments and strengths. A modular formulation strategy offering the possibility of rapid prototyping was applied. Different tablet compositions and the resulting tablet characteristics were investigated for dispersible tablets using customized analytical methods. METHODS: Fluid bed granules were blended with extragranular components, and compressed to tablets. Disintegration behavior was studied with a Texture Analyzer and a Tensiometer. RESULTS: Methods for determination of disintegration time and water uptake of tablets were developed with a Texture Analyzer, and a Tensiometer, respectively. Twenty-two different tablet formulations were prepared and analyzed with respect to disintegration time, hardness, friability, and viscosity. Multivariate data analysis revealed a high impact of type and amount of viscosity enhancer on the disintegration behavior of tablets. An optimized formulation was selected with a disintegration time of 24 s. CONCLUSION: Methods providing additional information on the disintegration behavior of dispersible tablets compared to standard pharmacopoeia methods were established. Selecting the right type and level of viscosity enhancer and superdisintegrant was critical for developing pediatric tablets with a disintegration time of less than 30 s but still pleasant mouth feel.
Authors: Witold Brniak; Renata Jachowicz; Anna Krupa; Tomasz Skorka; Krzysztof Niwinski Journal: Pharm Dev Technol Date: 2012-08-13 Impact factor: 3.133
Authors: Anne Zajicek; Michael J Fossler; Jeffrey S Barrett; Jeffrey H Worthington; Robert Ternik; Georgia Charkoftaki; Susan Lum; Jörg Breitkreutz; Mike Baltezor; Panos Macheras; Mansoor Khan; Shreeram Agharkar; David Douglas MacLaren Journal: AAPS J Date: 2013-08-02 Impact factor: 4.009