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Development and Evaluation of Orodispersible Tablets Containing Ketoprofen

Author(s):

Laiane J. Oliveira, Andressa Veiga, Nayana C. F. Stofella, Aline C. Cunha, Maria da Graça T. Toledo, Itamar F. Andreazza and Fabio S. Murakami*   Pages 1 - 13 ( 13 )

Abstract:


Aims:Development of orodispersible tablets using different methodologies

Background: Orodispersible tablets (ODTs) are an option to facilitate the intake of pharmaceutical solid dosage forms, which dissolve in the mouth within 30 seconds releasing the drug immediately with no need for water intake or chewing.

Objective: The main goal of our study is the technological development of lactose free orodispersible tablets that contain ketoprofen.

Method: We assessed different variables during the pharmacological development of ODTs: compression techniques conducted after a wet granulation process, aiming to optimize the flow properties of the formulation, and a suspension freeze-drying molded in blisters. We developed three formulations for each method, each containing one of the superdisintegrants: croscarmellose, crospovidone, or starch glycolate.

Result: During the production of ODTs, we performed a quality control of the granulation process, since the production of pellets contributed to the enhancement of the disintegration time and content homogeneity. Quality control tests for ODTs produced by freeze-drying were also satisfactory, despite significant changes in the final physical aspect of these products when compared to that of ODTs produced by compression. In addition, the disintegration times of ODTs produced by freeze-drying were substantially higher. Furthermore, these tablets displayed greater friability and pose a challenge to the control of a standard individual weight.

Conclusion: Among the superdisintegrants, croscarmellose contributed the most significantly to reduce the disintegration time and to dissolve the KTP effectively in 20 minutes.

Keywords:

Pharmaceutical Dosage Forms, Dissolution Efficiency, Development of Formulations, Freeze-Drying, Granulation, Direct Compression.

Affiliation:

Universidade Federal do Paraná, Farmácia Department , Universidade Federal do Paraná, Farmácia Department , Universidade Federal do Paraná, Farmácia Department , Universidade Federal do Paraná, Farmácia Department , Universidade Federal do Paraná, Farmácia Department , Universidade Federal do Paraná, Farmácia Department , Universidade Federal do Paraná, Farmácia Department



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