Abstract
Objective: The present study aimed to formulate and evaluate the formulated sustained-release floating matrix tablets of valganciclovir hydrochloride to produce a stable and bioavailable dosage form.
Methods: The tablets were prepared using hydrophilic and hydrophobic polymers such as ethyl cellulose, Hydroxy-propyl methylcellulose (HPMC), and Povidone. The formulations were subjected to evaluation characteristics such as drug content, hardness, friability, floating lag time, total floating time, and In vitro drug dissolution studies.
Results: The formulation composition and method of manufacturing are novel for this particular active moiety and robustness was assessed using a central composite design. All the formulation trials exhibited more than 90% of drug release in 12 h duration, with a floating lag time of more than 11 h, and drug content was found more than 90% across the batches. The hardness and friability profiles were found to be uniform across the batches. The preliminary evaluation confirms the received drug is pure and FTIR results show that the drug and excipients are compatible. The hardness and friability profiles were found consistent across the batches. All the formulation trials of central composite design have shown more than 90% of drug release in 12 h duration, with a floating lag time of more than 11 h, and drug content was found more than 90% across the batches.
Conclusion: The formulated valganciclovir hydrochloride sustained release floating matrix tablets showed an increased GRT with a sustained release for 12 h, thereby allowing a better window for absorption and consequently improving the drug's therapeutic effect.
Publisher
Innovare Academic Sciences Pvt Ltd
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