Abstract

Title : Development of verapamil hydrochloride orally disintegrating tablets using sublimation method by microwave irradiation
By : Piyawan Taopatom and Ratiporn Wongjumpoo
Degree : DOCTOR OF PHARMACY
Advisor : Asst.Prof.Dr.Utsana Puapermpoonsiri , Dr.Sureewan Duangjit and Asst.Prof.Dr.Warisada Sila-on
Keywords : Verapamil HCl, ODTs, diluents, sublimating agent, microwave irradiation
   
Oral Disintegrating Tablets (ODTs) with good performance are able to disintegrate within 30 seconds, but they are high porosity and fragile. They need to use the expensive special package. So that, several attempts has been investigated to develop the desirable hardness and simple producing process. Objectives: To study the influence of sublimating agents and diluents on the characteristics of ODTs of verapamil HCl. Methods: ODTs composed of verapamil HCl (40 mg), sweetening agent (10mg), adsorbents (5 mg), sublimating agents such as ammonium bicarbonate (10 mg) and diluents including Avicel PH 102 and mannitol adjusted to 260 mg of tablet weight. Compressed to tablet with hydraulic compactor by direct compression method and then treated with microwave oven at power of 900 watts for 6.30 min. The characteristics of tablets including hardness, friability, disintegration time, content uniformity and in vitro dissolution were determined.Results: ODTs of verapamil HCl consisted of ammonium bicarbonate and the mixture of Avicel PH 102 and Mannitol (ratio 1:1), as sublimating agent and diluents, respectively, demonstrated the desirable characters. They presented 6.083±0.67 kg of hardness with low friability. They disintegrated within 6.4±1.9 min. The content of active drug were within 90.0-110.0%and showed the maximum dissolution rate. Conclusion: Heat generated from microwave irradiation caused the sublimating agent sublimed and produced the porosity within tablets. These led to the rapid disintegration and dissolution of tablets. While, sugar alcohol as diluent was melted resulting in the increasing of tablet strength. These provided the appropriate characteristic of tablets.
   
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