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Nghiên cứu bào chế viên nifedipin giải phóng kéo dài theo cơ chế bơm thẩm thấu kéo – đẩy

Bài viết khảo sát ảnh hưởng của các yếu tố thuộc về công thức đến giải phóng của thuốc, từ đó lựa chọn ra các thành phần của viên nifedipin giải phóng kéo dài dựa trên hệ số f2 thu được khi so sánh đồ thị hòa tan của viện nghiên cứu với viên Adalat LA. | VNU Journal of Science Medical and Pharmaceutical Sciences Vol. 36 No. 4 2020 12-22 Original Article Preparation of Nifedipine Push-Pull Osmotic Pump Tablets Tran Quang Trung1 Nguyen Thi Dao2 Nguyen Thanh Hai3 Trinh Van Lau4 1 Vietnam Military Medical University 160 Phung Hung Phuc La Ha Dong Hanoi Vietnam 2 Thanh Phat Pharmacy Joint Stock Company Phu Nghia Industrial Zone Chuong My Hanoi Vietnam 3 VNU University of Medicine and Pharmacy 144 Xuan Thuy Cau Giay Hanoi Vietnam 4 National Institute of Drug Quality Control 48 Hai Ba Trung Hoan Kiem Hanoi Vietnam Received 04 November 2020 Revised 23 November 2020 Accepted 23 November 2020 Abstract This study aims to investigate the influence of the formulation factors on the drug release kinetics thereby selecting the compositions of extended-release nifedipine tablet based on the similarity coefficient f2 obtained when compared with Adalat LA tablet. The formulation factors such as molecular weight of the polyethylene oxide PEO and osmotic agent amount in drug layer and push layer semi permeable membrane thickness estimated by coating weight gain orifice size type of plasticizers and ratios of coating polymer to plasticizer in semipermeable membrane were evaluated. It was found that developed tablets were able to deliver nifedipine in an approximate zero-order manner up to 20 hours and drug release profile of developed tablets was similar to that from Adalat LA tablets. The developed tablet contained PEO N10 PEO 303 in drug layer and push layer respectively percentages of osmotic agent in drug layer and push layer were 10 and 30 respectively weight gain of semipermeable coating was 12 and orifice size was 0.8 mm. Keywords Nifedipine GPKD push-pull osmotic pump PEO T lag. ____ Corresponding author. E-mail address tqt201316@gmail.com https doi.org 10.25073 2588-1132 vnumps.4284 12 T.Q. Trung et al. VNU Journal of Science Medical and Pharmaceutical Sciences Vol. 36 No. 4 2020 12-22 13 Nghiên cứu bào chế viên nifedipin