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Development of Oral Flexible Tablet (OFT) Formulation for Pediatric and Geriatric Patients: a Novel Age-Appropriate Formulation Platform

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ABSTRACT

Development of palatable formulations for pediatric and geriatric patients involves various challenges. However, an innovative development with beneficial characteristics of marketed formulations in a single formulation platform was attempted. The goal of this research was to develop solid oral flexible tablets (OFTs) as a platform for pediatrics and geriatrics as oral delivery is the most convenient and widely used mode of drug administration. For this purpose, a flexible tablet formulation using cetirizine hydrochloride as model stability labile class 1 and 3 drug as per the Biopharmaceutical Classification System was developed. Betadex, Eudragit E100, and polacrilex resin were evaluated as taste masking agents. Development work focused on excipient selection, formulation processing, characterization methods, stability, and palatability testing. Formulation with a cetirizine-to-polacrilex ratio of 1:2 to 1:3 showed robust physical strength with friability of 0.1% (w/w), rapid in vitro dispersion within 30 s in 2–6 ml of water, and 0.2% of total organic and elemental impurities. Polacrilex resin formulation shows immediate drug release within 30 min in gastric media, better taste masking, and acceptable stability. Hence, it is concluded that ion exchange resins can be appropriately used to develop taste-masked, rapidly dispersible, and stable tablet formulations with tailored drug release suitable for pediatrics and geriatrics. Flexible formulations can be consumed as swallowable, orally disintegrating, chewable, and as dispersible tablets. Flexibility in dose administration would improve compliance in pediatrics and geriatrics. This drug development approach using ion exchange resins can be a platform for formulating solid oral flexible drug products with low to medium doses.

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ACKNOWLEDGEMENTS

The authors would like to express gratitude to Orchid Healthcare Limited, India, and Novel Laboratories Inc., Bangalore, for supporting this research work. The authors kindly acknowledge the Department of Science and Technology, New Delhi, Govt. of India, for its efforts in establishing the National Facility for Drug Development for Academia, Pharmaceutical and Allied Industries at Bharathidasan Institute of Technology, Anna University, Tiruchirappalli, and for providing constant support.

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Authors and Affiliations

  1. Department of Pharmaceutical Technology, Centre for Excellence in Nanobio Translational Research, Bharathidasan Institute of Technology Campus, Anna University, Tiruchirappalli, TN, 620024, India

    Prabagaran Chandrasekaran & Ruckmani Kandasamy

  2. National Facility for Drug Development for Academia, Pharmaceutical and Allied Industries, Department of Pharmaceutical Technology, BIT Campus, Anna University, Tiruchirappalli, TN, 620024, India

    Ruckmani Kandasamy

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  1. Prabagaran Chandrasekaran
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  2. Ruckmani Kandasamy
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Correspondence to Ruckmani Kandasamy.

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Chandrasekaran, P., Kandasamy, R. Development of Oral Flexible Tablet (OFT) Formulation for Pediatric and Geriatric Patients: a Novel Age-Appropriate Formulation Platform. AAPS PharmSciTech 18, 1972–1986 (2017). https://doi.org/10.1208/s12249-016-0666-0

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