Nghiên cứu bào chế vi nhũ tương diclofenac định hướng dùng trên mắt=Preparation of diclofenac microemulsion as an ocular delivery system

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Tác giả: Thị Ánh Nhật Hoàng, Thị Thanh Duyên Nguyễn, Văn Hùng Phạm

Ngôn ngữ: vie

Ký hiệu phân loại:

Thông tin xuất bản: Tạp chí Y học Việt Nam (Tổng hội Y học Việt Nam), 2024

Mô tả vật lý: tr.289-297

Bộ sưu tập: Báo, Tạp chí

ID: 478020

Thêm vào giỏ

Bào chế được vi nhũ tương acid diclofenac 0,093% (tương ứng natri diclofeac 0,1%) có một số chỉ tiêu chất lượng phù hợp để định hướng dùng trên mắt. Giản đồ pha trắng không chứa dược chất được xây dựng bằng phương pháp chuẩn độ nước. Các mẫu vi nhũ (VNT) tương acid diclofenac với các thành phần được lựa chọn từ giản đồ pha được bào chế và đánh giá một số đặc tính như kích thước tiểu phân, phân bố kích thước tiểu phân, khả năng giải phóng dược chất qua màng, pH, chỉ số khúc xạ (RI), sức căng bề mặt, phương pháp tiệt khuẩn và khả năng kích ứng mắt. Các mẫu VNT M1, M6, M7 chứa acid diclofenac, dầu IPM, chất diện hoạt Tween 80, chất đồng diện hoạt Transcutol P, chất bảo quản benzalkonium chlorid, pha nước lần lượt là nước tinh khiết, đệm phosphat và đệm borat có kích thước giọt trong khoảng 17-21 nm với phân bố hẹp (PDI <
0,25). Giá trị pH, RI, sức căng bề mặt phù hợp dùng trên mắt. Hấp tiệt khuẩn là một phương pháp tiệt khuẩn vi nhũ tương tiềm năng trong nghiên cứu này. Mẫu M1, M6, M7 có mức độ kích ứng mắt nhẹ, tỷ lệ dược chất giải phóng cao trong các thời điểm đầu và có tiềm năng giải phóng dược chất kéo dài (trên 8 giờ).The aim of this study is to develop a microemulsion (ME) containing 0.093% diclofenac acid (equivalent to 0.1% diclofenac sodium) for ocular delivery that can provide extended release of diclofenac acid (DA) and evaluate some properties of microemulsions. Phase diagrams were constructed by the titration method. The MEs containing DA using the selected phase diagram were prepared by phase titration and characterized by physical stability, particle size and distribution, in vitro release, pH, refractive index (RI), surface tension, sterilization method, and potential ocular irritancy. These MEs M1, M6, and M7 containing DA, isopropyl myristate (oil phase), Tween 80 (surfactant), Transcutol P (co-surfactant), and benzalkonium chloride (preservative), along with the respective aqueous phases of purified water, phosphate buffer, and borate buffer, had the average droplet size formed in the range of 17-21 nm with a narrow distribution (polydispersity index (PDI) <
0.25). The pH, RI, and surface tension of the formulations are appropriate for ocular application. Autoclaving is a viable method for sterilizing microemulsions in this study. ME from M1, M6, and M7 formulas were associated with mild ocular irritation, a high drug release rate during the initial stages (approximately 50% within 4 hours), and the potential for extended drug release (over 8 hours).

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