抗精神病药物透皮贴片的设计和开发:体外和离体表征

Himabindu Peddapalli, Anjaneyulu Rajagoni, Preethi Pagilla, Jerusha Perumala, Shilpa Puppala, K. Sunand, V. Bakshi
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引用次数: 0

摘要

本研究的目的是设计、评估和评估已开发的含盐酸左舒必利的透皮基质型制剂,目的是提高患者的生物利用度和依从性。以羟丙基甲基纤维素(HPMC) e15、乌木油rl100和乌木油RS100为原料,采用溶剂铸造法制备了左硫吡脲透皮膜。在目前的研究工作中,丙二醇和油酸分别作为增塑剂和不同组分的渗透增强剂。在这些批次中,所有制剂的药物含量均匀度在91.6% ~ 98%之间。贴片的折叠耐久性好,柔韧性好。经冲洗的透皮膜具有必要的物理化学性质,如药物含量均匀性、重量、厚度、折叠耐久性和湿度含量。Franz扩散池用于体外扩散研究,以透析膜为扩散边界。配方F5(乌龙茶RL 100-1%, HPMC E15-9%) 12 h的释药一致性最好,释药度为97.76%。f5是最令人满意的配方,因为它严格符合标准,并且连续渗透药物12小时,可以保持血浆中所需的治疗浓度。这些贴片暴露于瞬态稳定性研究中,观察到它们是恒定和稳定的。
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Design and Development of Transdermal Patches of Antipsychotic Drug: In vitro and Ex vivo Characterization
The purpose of the present research work was to design, assess, and estimate the developed transdermal matrix-type formulation comprising levosulpiride hydrochloride with the objective of enhancing the bioavailability and compliance of the patient. Transdermal films of levosulpiride were developed using a solvent casting method by hydroxypropyl methylcellulose (HPMC) E 15, Eudragit RL 100, and Eudragit RS100. In current research work, propylene glycol and oleic acid was used as plasticizer and permeation enhancers in different fractions. Among the batches, drug content uniformity with all formulations was perceived between 91.6 to 98%. Folding endurance of patches was good and indicates satisfactory flexibility. Developed transdermal films had the necessary physicochemical properties, for example, uniformity of drug content, weight, thickness, folding endurance, and dampness content. Franz diffusion cell was used for in vitro diffusion studies utilizing dialysis membrane as a pervasion boundary. Formulation F5 (Eudragit RL 100-1%, HPMC E15-9%) was found to be best among all batches of its consistent release rate for 12 hours and the extent of drug release 97.76%. F5 was the most palatable formulation as it firmly meets the standards and continuously permeated drugs for 12 hours that can keep up desired therapeutic concentration in plasma. The patches were exposed to transient stability studies and were observed to be constant and stable.
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