Carbamazepine Sustained Release Tablets

Objective:Carbamazepine (Carbamazepine, CBZ) is a broad-spectrum anti-epileptic drug is effective for the treatment of epilepsy, peripheral neuropathic pain, manic depression, alcohol withdrawal syndrome and diabetes insipidus central part, it is healthy for children central District discharge stove epilepsy drug of choice. Carbamazepine is a white or almost white crystalline powder, polymorphs, poorly compressible drug, soluble in chloroform, slightly soluble in ethanol, almost insoluble in water or ether. Carbamazepine polymorphs complex, there are four crystal, anhydrous crystal in contact with water can be gradually transformed into less soluble dihydrate, while the grain size increases, resulting in drug release difficult. The drug’s therapeutic plasma concentrations and half-life individual differences, easy to produce a variety of side effects, even life-threatening. In order to reduce the adverse reactions of drugs and medication procedures simplified, at home and abroad it has been listed a variety of specifications of sustained-release tablets and extended-release capsules. But not designed for children of low-dose sustained-release formulation currently on the market. Children in rapid growth stage, in which the body organ function is not yet mature, epilepsy and antiepileptic drugs would cause some children with special harm. This topic plans for pediatric patients, develop specifications for the 50mg sustained release carbamazepine tablets for domestic pharmaceutical companies to provide references.Methods:On the basis of the full study drugs and a variety of accessories on nature to hydroxypropyl methyl cellulose, lactose, sodium lauryl sulfate, magnesium stearate coating material prepared specifications for the 50mg dose of carbamazepine little slow release tablets. It has been optimized for a variety of materials screening with a best release preparation process, on this basis, on a small pilot test. USP standards and new drug with standard dissolution testing positive it with Chengdu-Alliance Pharmaceutical Co., Ltd. of carbamazepine extended release of sustained-release tablets were compared. It requires reference drug stability testing guidelines for appearance, release, content, and other projects related substances as the marker of homemade specification of carbamazepine extended release tablets 50mg initial stability test.Results:The optimal formulation and preparation process from products carbamazepine sustained release tablets. In the homemade process, from product appearance, content and in vitro release and other indicators no significant difference compared with the reference formulation, quality control basically the same. Prescription optimized production of carbamazepine extended release tablets showed a zero order release characteristics, release completely and inter-assay reproducibility. Stability test of the study parameters were not changed significantly.Conclusion:Preferred sustained release carbamazepine tablets (50mg/tablet) formulation is reasonable, technology is feasible, reliable, good stability and low cost, this information can provide a reference for domestic pharmaceutical companies.