Design and analysis of lyophilized formulation for extending shelf life of Tuberculin PPD
1
Issued Date
2005
Copyright Date
2005
Resource Type
Language
eng
File Type
application/pdf
No. of Pages/File Size
xi, 56 leaves : ill. (some col.)
ISBN
9740456626
Access Rights
open access
Rights
ผลงานนี้เป็นลิขสิทธิ์ของมหาวิทยาลัยมหิดล ขอสงวนไว้สำหรับเพื่อการศึกษาเท่านั้น ต้องอ้างอิงแหล่งที่มา ห้ามดัดแปลงเนื้อหา และห้ามนำไปใช้เพื่อการค้า
Rights Holder(s)
Mahidol University
Bibliographic Citation
Thesis (M.Sc. (Medical Technology))--Mahidol University, 2005
Suggested Citation
Thipchuta Bharnthong Design and analysis of lyophilized formulation for extending shelf life of Tuberculin PPD. Thesis (M.Sc. (Medical Technology))--Mahidol University, 2005. Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/106064
Title
Design and analysis of lyophilized formulation for extending shelf life of Tuberculin PPD
Alternative Title(s)
การสร้างและวิเคราะห์สูตรตำรับของทูเบอร์คูลินพีพีดีชนิดแห้งเพื่อเพิ่มอายุในการใช้งาน
Author(s)
Abstract
Tuberculin test is currently used for diagnosis and epidemiological surveys of tuberculosis. Mantoux method involves the intradermal injection of purified protein derivative (PPD) at the International unit dose. This study aimed to develop a dry PPD preparation to extend the shelf life of tuberculin PPD. Therefore, 5.0% Sucrose (S), 6.5% Mannitol (M), 2.5% Trehalose (T) and 0.3% Haemaccel (H) were added to each formulation. In vivo and in vitro analyses were carried out after lyophilization in order to determine the efficacy of the tuberculin activity. In the in vivo test, the activities of tuberculin shown by Delayed type hypersensitivity (DTH) responses to lyophilized preparations were compared to DTH responses to liquid preparation (CL) after injection into Bacillus Calmette Guerin (BCG) vaccinated guinea pigs. The results from preparations with added H, M, T, and S were 100%, 90%, 89%, and 60% of those from CL respectively. There was no loss of tuberculin activity in H formula. A statistically significant difference was found between S and CL (P <0.05). The cellular test for Interferon-gamma (IFN-γ) secretions was performed by using whole blood of human subjects screened for having DTH responses to tuberculin PPD Mantoux tests. They were assayed for Cell mediated immunity (CMI) responses caused by the stimulation of tuberculin antigens in the formulations. The detection of IFN-γ secretions was done by using Enzyme-Linked Immunosorbent Assay and the efficacy was expressed in terms of percentage of IFN-γ responses to tuberculin antigens. The results of CL, H, M, T and S were 3.28%, 10.40%, 0.84%, 1.52% and 1.29% respectively. The lyophilized H, M and T formulations and the liquid CL were studied for their shelf-life stabilities. Accelerated degradation was induced by storing the samples at 4°C and higher temperatures of 37°C and 56°C for 3, 6, 9 and 12 months. All tuberculin PPD solutions were injected into BCG vaccinated guinea pigs at the end of each storage period and the;"การทดสอบการติดเชื้อวัณโรคด้วยทูเบอร์คูลินในปัจจุบันยังนิยมใช้วิธี Mantoux ที่ใช้ทูเบอร์คูลินชนิด purified protein derivative (PPD) ฉีดเข้าชั้นผิวหนังตามขนาดฉีดมาตรฐาน ซึ่งน้ำยามีความเจือจางสูงของปริมาณโปรตีน ทำให้ไม่มีความคงทน อายุของน้ำยาสั้น งานวิจัยนี้มีวัตถุประสงค์ในการพัฒนาสูตรตำรับทูเบอร์คูลิน PPD เป็นชนิดแห้งเพื่อยืดอายุการใช้งา"
Description
Medical Technology (Mahidol University 2005)
Degree Name
Master of Science
Degree Level
Master's degree
Degree Department
Faculty of Medical Technology
Degree Discipline
Medical Technology
Degree Grantor(s)
Mahidol University