摘要
Introduction: Moisture permeability and a loose closure system might allow a significant gain of moisture into container and this could lead to significant loss of potency of drug sensitive to moisture and as well promoting the growth of microorganisms. Typical examples of the drugs sensitive to moisture include Tenofovir Disoproxil Fumarate (TDF). Product claimed to be a “Tight container” does not make it a tight container until proved practically. A plastic container is tight if “not more than one of the 10 tested containers exceeds 100 mg per day per L in moisture permeability. Objectives: The goal of this study was to determine rate of moisture permeability of selected High Density Polyethylene plastic bottles for packaging of moisture sensitive medicines in particular Lamivudine/Tenofovir Disoproxil fumarate tablets. Methodology: The determination of rate of moisture permeability was achieved by assessing closure systems of plastics as per USP 37 method, while the difference in absorption pattern was achieved by assessing the spectrum obtained through transmittance by Fourier Transform-Infrared (FT-IR). The plastic bottles were randomly selected from supplier A, B and C. Results: The plastic bottles from supplier A and B had an average moisture permeability of 12.57 and 51.55 mg/day/L with none of the containers exceeding moisture permeability of 100 mg/day/L whereas containers from supplier C had an average of 149.95 mg/day/L with seven of the containers exceeding of 100 mg/day/L. Conclusion: Containers from supplier A and B met the USP specifications hence could be used as primary packaging for moisture sensitive medicines whereas the containers from supplier C did not meet the USP specifications for them to be regarded as “Tight Containers” and hence, unsuitable for packaging of moisture sensitive medicines.
Introduction: Moisture permeability and a loose closure system might allow a significant gain of moisture into container and this could lead to significant loss of potency of drug sensitive to moisture and as well promoting the growth of microorganisms. Typical examples of the drugs sensitive to moisture include Tenofovir Disoproxil Fumarate (TDF). Product claimed to be a “Tight container” does not make it a tight container until proved practically. A plastic container is tight if “not more than one of the 10 tested containers exceeds 100 mg per day per L in moisture permeability. Objectives: The goal of this study was to determine rate of moisture permeability of selected High Density Polyethylene plastic bottles for packaging of moisture sensitive medicines in particular Lamivudine/Tenofovir Disoproxil fumarate tablets. Methodology: The determination of rate of moisture permeability was achieved by assessing closure systems of plastics as per USP 37 method, while the difference in absorption pattern was achieved by assessing the spectrum obtained through transmittance by Fourier Transform-Infrared (FT-IR). The plastic bottles were randomly selected from supplier A, B and C. Results: The plastic bottles from supplier A and B had an average moisture permeability of 12.57 and 51.55 mg/day/L with none of the containers exceeding moisture permeability of 100 mg/day/L whereas containers from supplier C had an average of 149.95 mg/day/L with seven of the containers exceeding of 100 mg/day/L. Conclusion: Containers from supplier A and B met the USP specifications hence could be used as primary packaging for moisture sensitive medicines whereas the containers from supplier C did not meet the USP specifications for them to be regarded as “Tight Containers” and hence, unsuitable for packaging of moisture sensitive medicines.
作者
Raphael Shedafa
Prosper Tibalinda
Vicky Manyanga
Joseph Sempombe
Marry Temu
Nelson Masota
Eliangiringa Kaale
Christoph Bonsmann
Raphael Shedafa;Prosper Tibalinda;Vicky Manyanga;Joseph Sempombe;Marry Temu;Nelson Masota;Eliangiringa Kaale;Christoph Bonsmann(Medicinal Chemistry Department, Muhimbili University of Health and Allied Sciences (MUHAS), Dar-es-Salaam, Tanzania;Pharm R&D Laboratory, School of Pharmacy, Muhimbili University of Health and Allied Sciences (MUHAS), Dar-es-Salaam, Tanzania;Department of Pharmaceutics and Pharmacy Practice, Muhimbili University of Health and Allied Sciences (MUHAS), Dar-es-Salaam, Tanzania;German Medical Aid Organization, Tonisvorst, Germany)
