Controlled Release

The aim of the present work is to develop hydrophilic and hydrophobic polymer based control release matrix tablet of Ropinirole HCl (RPN) which can release the drug up to time period of 24 hr. Ropinirole is a non-ergoline dopamine agonist. Its biological half-life is about 5-6 hrs periods, It is given in dose of 8-10mg/day; it requires multiple dosing to maintain therapeutic drug blood levels. The most frequent side effect of RPN Immediate Release(IR) dosage form is fluctuations in plasma level concentration of drug which may lead to development of some symptoms of Parkinson Disease (PD). To avoid this, the control release formulation maintains steady plasma level concentration of drug throughout a period of 24 hrs, which avoids the symptom of PD. Differential scanning calorimetric analysis confirmed the absence of any drug polymer interaction. In present work different matrices are used to control release of Ropinirole. HPMC K100M, HPMC K15M, Gum guar, PEO etc. are used as Hydrophilic Release Rate Modifier. Hydrophobic release rate used are Ethyl cellulose, Glyceryl Monostearate, Hydrogenated Castor Oil. Tablets (F1-F12, F29-F35) were prepared by Direct Compression and other batches (F12-F25) by Melt Granulation Technique. The tablets were evaluated for thickness, diameter, weight variation test, hardness, friability, and drug content. In vitro drug release studies were carried out in citrate buffer (pH 4) using a USP II dissolution apparatus at 100 rpm, Batch F29 give 96% CDR till the period of 24 hr, it also avoids initial burst release. The best fit model for F29 formulation follows Zero order  (r2= 0.989) and n value was found to be 0.91 which signified that release pattern of optimized batch F29 follows the Fickian diffusion. SEM study of F29 was also performed. During Accelerated Stability studies formulation F29 was found to be stable. Thus the matrix tablets of Ropinirole HCl were prepared successfully.

The objective of the present study was to prepare in situ hydrogel for controlled release of ofloxacin using various polymers such as Poloxamer P407, Sodium Alginate and Polyox. In situ were characterized for the Appearance, pH determination, In vitro Gelation studies and viscosity, Rheological studies, Drug Content, In vitro Drug release study, Sterility testing. Drug-excipient compatibility was determined by FTIR. Infrared spectroscopy studies of Ofloxacin, Polyox, Sodium alginate, Poloxamer and HPMC K4M alone and their physical mixture revealed that, Ofloxacin is compatible with all the polymers used. The clarity of the prepared formulations was found satisfactory. The pH of all formulations was found to be satisfactory in the range. The drug content of the prepared formulation was within the acceptable range, and ensures dose uniformity. The curve fitting data revealed that the release followed zero order kinetics.