<abstract xmlns="http://www.w3.org/1999/xhtml"><p> This study was aimed at developing risperidone oral disintegrating mini-tablets (OD-mini-tablets) as age-appropriate formulations and to assess their suitability for infants and pediatric use. An experimental Box-Behnken design was applied to assure high quality of the OD-mini-tablets and reduce product variability. The design was employed to understand the influence of the critical excipient combinations on the production of OD-mini-tablets and thus guarantee the feasibility of obtaining products with dosage form uniformity. The variables selected were mannitol percent in Avicel (X1), swelling pressure of the superdisintegrant (X2), and the surface area of Aerosil as a glidant (X3). Risperidone-excipient compatibilities were investigated using FTIR and the spectra did not display any interaction. Fifteen formulations were prepared and evaluated for preand post-compression characteristics. The prepared ODmini- tablet batches were also assessed for disintegration in simulated salivary fluid (SSF, pH 6.2) and in reconstituted skimmed milk. The optimized formula fulfilled the requirements for crushing strength of 5 kN with minimal friability, disintegration times of 8.4 and 53.7 s in SSF and skimmed milk, respectively. This study therefore proposes the risperidone OD-mini-tablet formula having robust mechanical properties, uniform and precise dosing of medication with short disintegration time suitable for pediatric use.</p></abstract>

This study was aimed at developing risperidone oral disintegrating mini-tablets (OD-mini-tablets) as age-appropriate formulations and to assess their suitability for infants and pediatric use. An experimental Box-Behnken design was applied to assure high quality of the OD-mini-tablets and reduce product variability. The design was employed to understand the influence of the critical excipient combinations on the production of OD-mini-tablets and thus guarantee the feasibility of obtaining products with dosage form uniformity. The variables selected were mannitol percent in Avicel (X1), swelling pressure of the superdisintegrant (X2), and the surface area of Aerosil as a glidant (X3). Risperidone-excipient compatibilities were investigated using FTIR and the spectra did not display any interaction. Fifteen formulations were prepared and evaluated for preand post-compression characteristics. The prepared ODmini- tablet batches were also assessed for disintegration in simulated salivary fluid (SSF, pH 6.2) and in reconstituted skimmed milk. The optimized formula fulfilled the requirements for crushing strength of 5 kN with minimal friability, disintegration times of 8.4 and 53.7 s in SSF and skimmed milk, respectively. This study therefore proposes the risperidone OD-mini-tablet formula having robust mechanical properties, uniform and precise dosing of medication with short disintegration time suitable for pediatric use.

Risperidone oral disintegrating mini-tablets: A robust-product for pediatrics

Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, King Abdulaziz University Jeddah, KSA

Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Al-Azhar University, Cairo Egypt

Research and Development Department, Deef Pharmaceutical Ind. Co., Qassim, KSA

Department of Pharmaceutics College of Pharmacy, Salman Bin Abdulaziz University, Alkharj, KSA

Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Zagazig University Zagazig, Egypt

Acta Pharmaceutica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

{"article-title":"Risperidone oral disintegrating mini-tablets: A robust-product for pediatrics"}

This study was aimed at developing risperidone oral disintegrating mini-tablets (OD-mini-tablets) as age-appropriate formulations and to assess their...

Risperidone oral disintegrating mini-tablets: A robust-product for pediatrics

Published Online: Dec 17, 2015

Page range: 365 - 382

Accepted: Jul 23, 2015

DOI: https://doi.org/10.1515/acph-2015-0038

Keywords
risperidone, mini-tablets, pediatrics, optimization design, disintegration

© by Ahmed S. Zidan

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Risperidone oral disintegrating mini-tablets: A robust-product for pediatrics

Published Online: Dec 17, 2015

Page range: 365 - 382

Accepted: Jul 23, 2015

DOI: https://doi.org/10.1515/acph-2015-0038

Keywordsrisperidone, mini-tablets, pediatrics, optimization design, disintegration

© by Ahmed S. Zidan

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Keywords
risperidone, mini-tablets, pediatrics, optimization design, disintegration