Abstract
Objective: The objective of the present work was to study the use of the sintering technique, a relatively new concept in pharmaceutical sciences, in the development of mucoadhesive buccal tablets for ivabradine Hydrochloride.
 Methods: The method consisted of blending drug, hydroxypropyl methylcellulose (HPMC K100M), carnauba wax, and other excipients followed by direct compression into tablets. The compressed fluffy matrices were sintered at two different constant temperatures like 50 °C and 60 °C for two different periods like 1.5 h and 3 h in a hot air oven. The effect of sintering on tensile strength, dissolution profile, and other parameters were studied. The drug-polymer-excipient compatibility was evaluated by Fourier transform Infrared (FTIR) and differential scanning calorimetric (DSC) studies.
 Results: The sintering condition markedly affected the drug release properties, hardness, and friability of the tablets. Based on the f2 similarity factor value, Ex-vivo mucoadhesive strength, Ex-vivo residence time, and in vitro dissolution studies, formulation F3SD was selected as an optimized formulation. Drug release followed a non-Fickian diffusion mechanism with the Higuchi model release kinetics. Stability studies of mucoadhesive buccal tablets in normal human saliva indicated the stability of the drug and buccal tablet in the oral cavity. Stability studies as per ICH guidelines revealed that optimized formulation was stable on storage conditions.
 Conclusion: The sintering technique provides a significant and convenient method for the development of a controlled release dosage form that can be used in the design of mucoadhesive buccal tablets of Ivabradine HCL.
Highlights
The buccal delivery system involves the administration of the required drug through the buccal mucosal membrane lining of the oral cavity in the mouth
Sintering was carried out at 50 °C and 60 °C for two different periods like 1.5 h and 3 h in a hot air oven. These temperatures were below the melting point of drug ivabradine HCL (198.30 °C, as shown in differential scanning calorimetric (DSC) studies) and polymers (170-180 °C and 80-88 °C for HPMC [25] and Carnauba wax [25] respectively)
Effect of sintering on physicochemical characteristics of buccal tablet The effects of sintering conditions on evaluation parameters of unsintered and sintered ivabradine mucoadhesive buccal tablets are shown in table 3
Summary
The buccal delivery system involves the administration of the required drug through the buccal mucosal membrane lining of the oral cavity in the mouth. The buccal region of the oral cavity is an attractive site for the administration of the drug of choice [1]. Buccal drug absorption can be quickly terminated in cases of toxicity by removing the dosage form from the buccal cavity. Buccal mucosa makes a more suitable choice of the site if prolonged drug delivery is desired because adhesion to sites such as oral cavities increases bioavailability by virtue of optimal contact with the adhesive surface which enhances absorption of the drug and prolongs gastric residence. Bucco-adhesive drug delivery systems have been developed basically to increase the retention of drugs in the oral cavity
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