Preparation and characterization of hydrogenated soybean oil as a controlled release regulator for metoprolol tartrate pellets
2
Issued Date
2023
Copyright Date
2006
Language
eng
File Type
application/pdf
No. of Pages/File Size
xviii, 174 leaves : ill
ISBN
9740470602
Access Rights
restricted access
Rights Holder(s)
Mahidol University
Bibliographic Citation
Thesis (Ph.D. (Pharmaceutics))--Mahidol University, 2006
Suggested Citation
Krisanin Chansanroj Preparation and characterization of hydrogenated soybean oil as a controlled release regulator for metoprolol tartrate pellets. Thesis (Ph.D. (Pharmaceutics))--Mahidol University, 2006. Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/88758
Title
Preparation and characterization of hydrogenated soybean oil as a controlled release regulator for metoprolol tartrate pellets
Alternative Title(s)
การเตรียมและตรวจสอบคุณลักษณะของน้ำมันถั่วเหลืองไฮโดรจีเนตเพื่อใช้เป็นสารควบคุมการปลดปล่อยยาเมโทโปรลอลทาเทรตจากเพลเลท
Author(s)
Advisor(s)
Abstract
The aims of this study were to prepare hydrogenated soybean oil (HSO) meeting the pharmaceutical specifications and to use tartrate pellets. Hydrogenation process was performed in a 2-liter batch agitated reactor with a 4-bladed disk turbine. A23 central composite design preparation.The reaction of catalyst, pressure. The was at 0.075% weight nickel, 0.86 MPa of pressure and 408 K of temperature. Increasing temperature increas ed the acid value of products. All products prepared at the optimum condition had quality conforming to hydrogenated vegetable oil type I USP 27/ NF 22. By DSC, HSM and XRD studies, HSO showed three main polymorphs namely α -, β ́- and β -form, listed in order of increasing thermodynamic stability. Aged HSO showed β ́- and β -form that are transformed to α - and β ́-form after melting. HSO was stable under high heating temperature in the range of 80-120°C and heat exposure at 100°C for 1 hour. Controlled release metopr olol pellets were prepared by hot melt fluid bed coating technique. The drug was dispersed in melted HS O and directly sprayed on nonpareils. The poor wettability of HSO enhanced the buoyancy of coated pellets in the in vitro study. Drug size fraction affected the size distribution of so lidified lipid droplets, coating structure and drug release. Increasing coating amount or a dding an additive revealed the decreased drug release. Drug release from coated pellets followe d a bi-phasic square-root-of-time kinetic, i.e., a burst release at the beginning (within the firs t 1 hour) followed by a slow release for 7 hours. The burst release is attributable to amount of coating, drug size fraction and to the inert additive which was added. Coated pellets showed three main polymorphs of HSO. Tempering process enhanced the β -form formation as crystal growth on the surface of coated pellets and revealed the increased drug release. In conclusion, HSO could be a promising material to control drug release in controlled release pellets based on its lipophilicity and buoyancy properties.
Degree Name
Doctor of Philosophy
Degree Level
Doctoral Degree
Degree Department
Faculty of Pharmacy
Degree Discipline
Pharmaceutics
Degree Grantor(s)
Mahidol University