Formulation and Evaluation of Olanzapine Oral Lyophilisates
Keywords:
Olanzapine, oral lyophilisates, rapidly disintegrating tablet, freeze dryingAbstract
One of the main obstacles to the development and delivery of drugs is poor drug solubility. Lyophilization is one of the common techniques that has been utilized to formulate alternative solid dosage forms that has the potential to improve drug delivery. In the present work, Olanzapine was manufactured using this technique to develop convenient and easy-to-administer rapidly disintegrating tablets as oral lyophilisates for the treatment of psychotic disorders.
By dispersing the medication in an aqueous solution of mannitol, MCC, various binders, and glycine, various formulations of Olanzapine oral lyophilisates were prepared. By assessing the hardness, disintegration time, wetting time, and dissolution time, the effect of mannitol, MCC, and various binders on the oral lyophilisates' properties was investigated. Furthermore, FTIR, DSC, and SEM were used to further characterize the produced oral lyophilisates.
The formed Olanzapine oral lyophilisates resulted in rapid tablet disintegration (11.6 to 23.5 sec) and a drug dissolution of 48.7% to 77.7% within two minutes. The FTIR spectra showed no drug-excipient interactions, while the DSC and SEM results show the crystalline state of Olanzapine in the pure drug and the physical mixture and there is clear evidence of transformation to the amorphous state during the formation of the oral lyophlisates. To conclude, this work succeeded in production of Olanzapine oral lyophilisates (Formula 7) with rapid disintegration, rapid dissolution and with no evidence for drug-excipient interactions.
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