Formulation and Evaluation of Modified Pulsincap Drug Delivery System for Chronotherapeutic Delivery of Montelukast Sodium

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.