Development and optimization of dextromethorphan hydrobromide oral disintegrating tablets: effect of formulation and process variables

作者：Mostafa Haitham Fady; Ibrahim Mohamed Abbas^*; Sakr Adel

来源：Pharmaceutical Development and Technology, 2013, 18(2): 454-463.

DOI：10.3109/10837450.2012.710237

• Oral disintegrating tablets
• factorial design
• dextromethorphan hydrobromide
• formulation variables
• process variables

Orally disintegrating tablets (ODTs), which disintegrate rapidly (%26lt;1 min) in the mouth and do not require water for administration, have become a very popular dosage form. The study aims to develop a simple and inexpensive method of manufacturing ODTs of a sparingly water-soluble drug, Dextromethorphan hydrobromide. Two factors, three levels (3(2)) full factorial design was used to optimize the diluent, microcrystalline cellulose (X-1) and superdisintegrant, croscarmellose sodium (X-2) concentrations. Disintegration time, hardness and T-50 values for all the formulations varied from 12.5 to 152.6 s, 3.58 to 4.92 kp and 0.8 to 2.8 min, respectively. The results indicated that the selected variables have a strong influence on disintegration time, hardness and T-50 of the ODTs. The manufactured ODTs formula composed of 30% microcrystalline cellulose in combination with 3% croscarmellose sodium was chosen as optimized formula, as it showed the lowest disintegration time (12.5 +/- 1.22 s), low T-50 (0.8 min.) and hard tablets (4.92 +/- 0.28 kp) amongst other tested ODTs formulations. Hardness of DM ODTs was not affected by changing the type of superdisintegrant and lubricant. The disintegration time was significantly (p %26lt; 0.05) increased by using sodium starch glycolate instead of croscarmellose sodium.

• 出版日期2013-4