Vol. 3 No. 1 (2022): Published
Following articles have been published in this issue:
1. IMPACT OF DIFFERENT EXCIPIENTS ON DISSOLUTION IMPROVEMENT OF LORATADINE BY SOLID DISPERSION
Abstract: Loratadine is one of the most commonly used anti-histamine. It is practically insoluble in water. The onset of the action of the Loratadine is delayed due to its poor aqueous solubility. Now a days, solid dispersion is an emerging technology in the pharmaceutical industry to increase the solubility of poorly soluble drug by using different polymer/ excipients. In this study, Peg 6000, Poloxomer 188 & 407, HPC, HPMC, Crospovidone, Croscarmellose and Kollicoat IR were used to formulate solid dispersion of Loratadine. In case of HPMC formulations, significant % release of drug was observed within 10 minutes. With the increase of HPMC from 71% to 83%, release was increased from 61.86% to 71.88% after 60 minutes. HPMC based solid dispersion formulation can be a way to improve dissolution of loratadine in commercial production.
2. A COMPREHENSIVE REVIEW OF A NEW NANOSUSPENSION FOR IMPROVING THE ORAL BIOAVAILABILITY OF POORLY SOLUBLE DRUGS
Abstract: Nanosuspension is a novel drug formulation for the delivery of hydrophobic drugs. The problem of medications that are poorly water-soluble and have low bioavailability is countered by nanosuspension technology. Solubility is a significant physiochemical element that influences drug absorption and therapeutic effectiveness. Poor aqueous solubility has the potential to impair formulation development. Nanosuspension technology can improve the drug's stability and bioavailability. Nanosuspensions can be formulated for various routes of administration such as oral, parenteral, ocular, topical, and pulmonary routes. Nanosuspension can be used for targeted drug delivery also by mucoadhesive gels and ocular inserts. Recent studies were approached to develop nanosuspension on site-specific drug delivery.
3. THE RISK-BASED APPROACH IN CASE OF A MATERIAL CHANGE IN PHARMACEUTICAL OPERATIONS
Abstract: Change of material source is very common in the pharmaceutical company. In general, the change of material triggers process validation. In this article, the need and extent of process validation have been discussed considering the risk-based approach. Risk assessment should be performed by comparison between old Vs new material, impact assessment due to material change, and material characterization where applicable. Based on risk assessment, it can be concluded that new material is ‘comparable and usable’ or ‘not comparable but usable’ or ‘not comparable and not usable.’ Accordingly, the need and extent for process validation and stability requirements can be concluded.
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