Martindale The Complete Drug Reference 38 Edition.rar
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The mechanism of drug inclusion into polysaccharide network could be the main cause of diazepam different release profile observed. The distinctive release profile of diazepam from gelatin and beta-glucan samples could be explained by hypothesizing that drug could be included into gelatin, the formation of the drug-gelatin complex being driven by the formation of hydrogen bonds between the drug and gelatin, not interacting with polysaccharide structure, while beta-glucan permits a gradual release of the drug due to the assumed drug-polysaccharide interaction.
Statistical parameters related to diazepam dissolution profile, such as dissolution efficiency and dissolution time, are reported in Table 5. In particular, the higher drug release for gelatin samples (p < 0.001) is confirmed by the lower values of dissolution efficiency. Besides, samples coated with 0.5% of beta-glucan present the shortest values of dissolution time. Finally, in the same conditions, the higher values of dissolution efficiency and dissolution time obtained for beta-glucan samples are probably due to the assumed drug-polysaccharide interaction.
In this study, diazepam sustained release pessaries have been developed by using two different polymers: gelatin and beta-glucan. Dissolution results pointed out that gelatin and beta-glucan could be used as vaginal pessaries' polymeric materials, as they are able to release the drug within 30 minutes. Moreover, diazepam pessaries formulation based on beta-glucan are able to release the drug according to a controlled release profile (p < 0.001). On the other hand, the pharmacological efficacy of diazepam is maintained even after 30 minutes of samples application, confirming the suitability of such formulation for the management of vaginal disorders.
The different release profiles obtained for gelatin and beta-glucan batches confirm the above discussed data, suggesting that diazepam could be enclosed into gelatin network without any interactions with polysaccharide structure, while beta-glucan could be a suitable material to be used as a matrix for sustained drug delivery systems, once it is able to retain diazepam in the vagina.
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