A new approach to improve the yield in the production of slow release oral dosage forms

Abstract

OBJECTIVE: The objectives of the study were to analyse a new improved method used for the production of pellets for the manufacture of solid oral dosage forms and to compare the new method with a method previously used and studied by Bartolo in 2011. METHOD: The parameters recorded during the production of slow release pellets were collected from the Batch Manufacturing and Instructions Record (BMIR). A total of eight batches were monitored and statistically analysed, using One Way Anova, to determine whether there is a statistically significant difference between the parameters of each batch. The mean surface rating of the pallets and the yield of the active pharmaceutical ingredient (API) obtained for the monitored batches, were statistically compared to those obtained in the previous study using the Independent Sample t-test. Statistical analysis was conducted using SPSS® version 20. KEY FINDINGS: Fine tuning in the control of all parameters during the manufacturing of different batches, even within established range, improves the yield of the final product. A statistically significant improvement in the mean pellets’ surface rating (p-value 0.004) and percentage yield of API (p-value 0.030) was observed in batches analysed in this study (4.75% and 94.09% respectively) when compared to batches analysed in the previous study (3.82% and 92.43% respectively) in 2011. The batches analysed during this study achieved the required dissolution rate after the application of the second slow release coating as opposed to the batches analysed in the earlier study, which required the application of a third slow release coating. CONCLUSION: The increase in the yield of API and improvement in the surface rating of the produced pellets implies that the new approach used for the production of slow release pellets is better and improved.