ABSTRACT

The aim of present investigation was formulation and development of Cinnarizine Sublingual Tablets. Study started from the Preformulation study of the drug. Drug belonged to BCS class-II and had low solubility properties. So, solubility enhancement technique is used namely spray drying technology. Solid dispersion technique is used to introduce solubility enhancer into the drug. The flow properties of API were found to be good enough, hence direct compression technique was used for tablet preparation. While studying IR spectrum, it was concluded that there was no interaction between drug and otherexcipients. Initially feasibility trials were taken to optimize three super disintegrants. Tablets were found acceptable in physical parameters evaluation. After preliminary screening, it was concluded that Crospovidone showed fastest rate of drug release. Based on that satisfactory batch considering for further factorial screening. 32 factorial design was applied by taking Crospovidone and Mannitol as independent factors. Factorial batch F1-F9 prepared by using direct compression method. Physical and chemical evaluation was done for all batches. Finally, from overlay plot Checkpoint batch (S1) was prepared and post compression parameters were evaluated and compared with optimised factorial batch F2 and found satisfactory. Finally optimized factorial batch F6 was loaded for stability study for 1 month and evaluation was done and found acceptable. Hence, F6 was the optimized formulation. Disintegration time was not more than 1 min which is good and desirable for sublingual dosage form. Its wetting time is 33 sec; and drug content was found to be100.0%. By looking all the above parameters, it is concluded that F6 formulation is optimizedformulation from all the batches and passes the entire evaluation test including stability studies. Keywords: Cinnarizine, motion sickness, Sublingual tablets, Crospovidone, Spray drying
Publication date: 01/12/2025

https://ijbpas.com/pdf/2025/December/MS_IJBPAS_2025_9623.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.12.9623