Research Journal of Pharmaceutical Dosage Form and Technology

V. Kalyani ¹, K. Basanthi ¹, T. E. G. K. Murthy ¹

Affiliations
1 Department of Pharmaceutics, Bapatla College of Pharmacy, Bapatla, Guntur District, IN

Abstract

Pulsatile drug delivery systems for Montelukast sodium were developed to release the drug at the desired time to improve the patient compliance. Preliminary studies were conducted to study the influence of diluents and disintegrants on dissolution of Montelukast sodium. Adequate strength and rapid drug release was observed from the granules formulated with the diluent (Mannitol: MCC blend) and Crosscaremellose sodium as disintegrating agent. The drug excipient compatibility studies were studied with IR spectra studies and they were found to be compatible. The capsules were evaluated for various compendia and non compendia quality control tests. All the formulated capsules satisfied the quality control requirements. Further the effect of polymer present in hydrogel plug filled in formaldehyde treated capsules. Among the hydrogen plugs, the plug containing HPMC K4M (A3-50mg) offered the required lag time of 5-5.30 hours and there after complete and immediate drug release was observed.

Keywords

Montelukast Sodium, Pulsatile Drug Delivery, Hydrogel Plugs.

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V. Kalyani ¹, V. Sai Kishore ¹, U. Kartheek ¹, S. Aruna ¹, A. Navya Krishna ¹

Affiliations
1 Department of Pharmaceutics, Bapatla College of Pharmacy, Bapatla, Guntur District, IN

Abstract

In the present study, natural gums (Hibiscus rosa-sinensis mucilage and Modified gum karaya) were investigated as superdisintegrants for use in immediate release tablet formulations containing olanzapine. Immediate release tablets of olanzapine were formulated using different concentrations (2, 3, 4, 5) of natural superdisintegrant viz; Hibiscus rosa - sinensis mucilage and modified gum karaya. Prepared tablets were evaluated for thickness, hardness, friability, uniformity of weight, disintegration time, wetting time and dissolution study. The formulated tablets had good appearance and better drug release properties. Modified gum karaya showed shorter disintegration time and showed 100% release is selected as optimized formulation. Immediate release tablet formulations containing modified gum karaya showed better dissolution efficiency property than the most widely used synthetic superdisintegrants. The dissolution rate followed first-order kinetics as the graphs drawn between log % drug unreleased vs time were found to be linear. The dissolution rate of Olanzapine was found to be effected by the concentration of the superdisintegrant used in the preparation of tablets. The formulation (F4) prepared with 5%w/w of modified gum karaya was offered relatively rapid release of Olanzapine when compared with other concentrations employed in this investigation. The difference factor (f1) and similarity factor (f2) were calculated for marketed formulation and for formulations prepared with modified gum karaya. The difference factor (f1) and similarity factor (f2) were found to be 12 and 68 respectively. Similarity factor (f2) is more than 50 and difference factor (f1) is less than 15, hence dissolution profiles are found to be similar.

Keywords

Olanzapine, Modified Gum Karaya, Hibiscus Rosa-Sinesis, Crospovidone.

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