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Document Details
Document Type
:
Thesis
Document Title
:
Development of Nano-Lipid Formula Containing Raloxifene and Vitamin D to Improve Their Bioavailability in Management of Osteoporosis
تطوير صياغة دهنية متناهية الصغر تحتوي على عقاري الرالوكسيفين وفيتامين د لتحسين التوافر الحيوي لهما في علاج هشاشة العظام
Subject
:
Faculty of Pharmacy
Document Language
:
Arabic
Abstract
:
Osteoporosis is a systematic skeletal disease in which the bone mass deteriorated and bone tissue developed fragility with great risk and susceptibility to fracture. Postmenopausal osteoporosis is the most common type of osteoporosis in women between 51 to 75 years old; it is a result of a cessation of ovarian function. Raloxifene hydrochloride (RLX) is a selective estrogen receptor modulator, and cholecalciferol (Vitamin D) is an important fat-soluble vitamin usually administrated concurrently as treatment of postmenopausal osteoporosis. The two drugs have low bioavailability due to absorption problems associated with low solubility. The aim of this research was to combine the two drugs in nanostructure lipid carriers (NLCs) as a drug delivery system, in order to overcome the previously mentioned drawbacks. RLX solubility was determined in different oils, solid lipids, and surfactants. Face centered central composite design (CCD) used to optimize RLX - Vit.D NLC and to study the effect of three independent formulation factor, namely; drug to total lipid ratio (X1), oil to solid lipid ratio (X2) and surfactant concentration (X3) on NLC particle size (PS), Entrapment efficiency (EE) of RLX and Vit.D, dissolution efficiency (DE) of RLX and Vit.D and permeation efficiency (PE) of RLX and Vit.D respectively. Pharmacokinetics parameters of optimized RLX-Vit. D NLCs were tested in healthy human volunteers and compared with marketed RLX and Vit.D commercial products. The results showed that the optimized RLX-Vit.D NLCs increased the maximum plasma concentration (Cmax) with a larger area under the curve (AUC) as a result enhanced the relative bioavailability of RLX to 385.6% in comparison to the marketed RLX commercial product. The level of [25(OH)D] rise significantly from the average baseline level which was 91±29 nmol/L to 174±36 nmol/L. Significant improve of RLX bioavailability encourages its use in the treatment of postmenopausal osteoporosis due to its superiority in enhancing RLX bioavailability compared to the commercial product.
Supervisor
:
Dr. Khaled Omar
Thesis Type
:
Master Thesis
Publishing Year
:
1441 AH
2020 AD
Added Date
:
Wednesday, March 11, 2020
Researchers
Researcher Name (Arabic)
Researcher Name (English)
Researcher Type
Dr Grade
Email
رهف هشام باحمدان
Bahmdan, Rahaf Hisham
Researcher
Master
Files
File Name
Type
Description
46056.pdf
pdf
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