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Document Details
Document Type
:
Thesis
Document Title
:
Preparation of Injectable Rosuvastatin in Situ Gel Formulation with Minimum Initial Drug Burst
تحضير مستحضر هلامي من الروزوفاستاتين يتصلب داخل الجسم معد للحقن و يتميز بإنطلاق أولي منخفض من الدواء
Subject
:
Faculty of Pharmacy
Document Language
:
Arabic
Abstract
:
Injectable in situ gel (ISG) system suffers from high initial drug release which may result in toxic effect. The rationale behind this work was to develop an optimized injectable rosuvastatin (RSV) ISG formulation characterized by minimum initial burst. Six formulation parameters have been screened, using the Plackett Burman design (PB), for their effect on RSV release in the first 24 h. Poly lactic acid-co-Ɛ-caprolactone (PLCL) concentration, poly lactic acid: poly caprolactone ratio, polyethylene glycol (PEG) molecular weight, PEG concentration, surfactant hydrophilic lipophilic balance (HLB) and surfactant concentration were screened. The most significant formulation factors were optimized using Box-Behnken design to achieve minimum RSV release after 0.5, 2 and 24 h. Physicochemical characterization for the optimized formulation components was studied. Pharmacodynamic effects of the optimized ISG formulation were studied and compared to ISG formulation containing 45 % PLCL (25: 75) loaded with raw RSV and to an oral marketed drug product. Result of the screening study revealed that PLCL (25: 75) concentration, surfactant HLB and surfactant: PEG 400 ratio were significantly affecting RSV release and their optimized levels are 45 %, 14.25 and 80:20, respectively. Physicochemical characterization demonstrated complete entrapment of RSV in the polymeric matrix and confirmed drug transformation to the amorphous state. Pharmacodynamic study revealed sustained reduction in the lipid profile that lasts for 21 days with a marked decrease in the lipid level during the first 24 h from the ISG system loaded with raw RSV. In conclusion, the optimized RSV ISG formulation can be considered as an alternative for the marketed drug oral daily tablets.
Supervisor
:
Dr. Tariq Abdulnabi
Thesis Type
:
Master Thesis
Publishing Year
:
1440 AH
2019 AD
Added Date
:
Monday, May 20, 2019
Researchers
Researcher Name (Arabic)
Researcher Name (English)
Researcher Type
Dr Grade
Email
محمد عبدالرحمن مصيري
Mussari, Mohammed Abdulrahman
Researcher
Master
Files
File Name
Type
Description
44456.pdf
pdf
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