RT info:eu-repo/semantics/article
T1 Drug Shelf Life and Release Limits Estimation Based on Manufacturing Process Capability.
A1 Oliva Martín, Alexis Manuel
A1 Llabrés Martínez, Matías Antonio
A2 Ingeniería Química y Tecnología Farmacéutica
A2 Desarrollo Galénico de Medicamentos
K1 Stability study
K1 Insulin
K1 Release limits
AB Specification limits are the competence regulatory agencies, whereas the release limit is a manufacturer’s internal specification to be applied at the time of batch release to assure that quality attributes will remain within the specification limits until the expiry time. The aim of this work is to propose a method to set the shelf life from drug manufacture process capacity and degradation rate, using a modified version of the proposed method by Allen et al. (1991) Two different data sets wereused to do this. The first data set corresponds to analytical method validation to measure the insulin concentration in order to estimate the specification limits, whereas the latter set gathered information on stability data of six batches of human insulin pharmaceutical preparation. In this context, the six batches were divided into two groups: Group 1 (batches 1, 2, and 4) was used to estimate shelf life; Group 2 (batches 3, 5, and 6) was used to test the estimated lower release limit (LRL). The ASTM E2709-12 approach was applied to verify that the future batches fulfill the release criterium. The procedure has been implemented in R-code.
SN 1999-4923
YR 2023
FD 2023
LK http://riull.ull.es/xmlui/handle/915/39713
UL http://riull.ull.es/xmlui/handle/915/39713
LA en
DS Repositorio institucional de la Universidad de La Laguna
RD 24-nov-2024