Formulation and evaluation of dexlansoprazole extended-release tablet

Dexlansoprazole (DSP) is a proton pump inhibitor, it used to treat GERD and ulcer colitis. DSP works by decreasing the volume of acid in the stomach. DSP is an acid-labile medication that may be destroyed in the stomach's acidic pH. A coating technique was used to postpone drug release in the stomach, which can extend pharmacological activity. Shellac can be used to develop the sustain release tablet of dexlansoprazole as retardation of the drug (dexlansoprazole) was observed in the acidic pH of the stomach, and hence a sustain coated dexlansoprazole tablet was prepared and evaluated. The coating's primary function is to allow for the delayed, immediate, and prolonged delayed release of DSP. DSP coating with different polymers inhibits faster degradation in the acidic pH of the stomach, therefore increasing pharmacological action. DSP coating with different polymers inhibits fast degradation in the stomach's acidic pH, enhancing pharmacological action. The major function of the coating is to enable for the delayed, immediate, and prolonged delayed release of DSP. DSP coating with different polymers inhibits fast breakdown in the stomach's acidic pH, enhancing pharmacological action.

Efficacy, safety, and retention rate of extended-release divalproex versus conventional delayed-release divalproex: A protocol for systematic review and meta-analysis

Review question / Objective: We aim to systematically examine and compare the efficacy, safety and retention rate of ER divalproex (VPA-ER) and conventional DR divalproex (VPA-DR) on patients with epilepsy. Condition being studied: To our knowledge, comparison and conversion studies about VPA-ER and conventional VPA-DR are lacked. Small-sample studies analyzing the safety and efficacy of VPA-ER in different populations remain controversial. Therefore, this study aims to systematically review the safety, efficacy and retention rate of VPA-ER and VPA-DR by meta-analysis.

FIXED-DOSE COMBINATION DRUGS AS TABLET IN TABLET: A REVIEW

The Pharmaceutical industry has become more interested in developing fixed-dose combinations (FDCs) in recent years. FDCs have been used successfully in a variety of clinical areas, including diabetes, HIV/AIDS,and cardiovascular diseases etc. FDCs are intended to extend the product life cycle and enhance patient compliance by decreasing cost. Active Pharmaceutical ingredients are chosen for FDC development based on variety of purposes such as Pharmacokinetic profile, drug-drug interactions, mechanism of action, and manufacturability for successful development. Tablet in tablet technology has gained popularity in recent years for creating modified release products. The compression coating or solvent-free-coating technology is also known as Tablet in Tablet technology. Tablet in Tablet technology is presently the finest alternative technology for the formulation of bilayer tablets for physical separation of active medicines and used to avoid chemical incompatibilities and to produce different drug release patterns such as rapid release, sustained release, controlled release, delayed release, and pulsatile release. This review mainly focuses on combining the techniques of both FDC and Tablet in Tablet formulations which offer a wide variety of benefits such as increased patient compliance, convenience, separation of incompatible ingredients, avoiding close interaction of two drugs, achieving various drug release patterns and maximizing the potency of both drugs over conventional oral dosage forms Keywords: Fixed dose combinations, Tablet in tablet technology, Compression coated tablet, Bilayer tablet, delayed release

Evaluating and Understanding the Reason for an Increase in Nonconformances in the Laboratory

This is a study of nonconformances experienced by a laboratory of a pharmaceutical manufacturing facility in East Africa. There has been an increase in nonconformances from 216 nonconformances in 2017 to 229 in 2018 and by September 2019, 306 nonconformances were already logged. Increasing nonconformances result in delayed release of tested materials and many resources are wasted (e.g. chemicals, man hours and equipment). Analysts become frustrated, which may result in inexhaustive investigations. Understanding the reason for the increase in nonconformances will enable the facility to derive effective solutions to the identified causes, hence reducing the number of nonconformances and improving the productivity and morale of employees. This quantitative, nonexperimental, longitudinal survey study was intended to evaluate and understand the reason for increasing nonconformances. Trends of the nonconformances, previous investigations, procedure for investigation and the training given to analysts have been reviewed. Laboratory incidences were the most recurring nonconformances; and these were mainly caused by analyst errors. Corrective and Preventive Actions (CAPAs) were derived by cross functional teams whenever root causes were identified. Procedure for investigation of nonconformances refers to investigative tools. Identification of root causes to nonconformances recently became mandatory. Analysts have limited advanced industrial training on investigation of nonconformances. Another study should be carried out to understand the cause of analyst errors. The study can be rolled out to other departments at the manufacturing facility to create similar improvements. Analysts should enroll into advanced courses of industrial pharmacy to gain advanced industrial skills which they can apply in investigations to find root causes to nonconformances.

941. Isavuconazole Prophylaxis Against Invasive Fungal Infection: A Pooled Analysis with a Comparison of Posaconazole Delayed-release Tablet Prophylaxis

Background There are limited data regarding the use of isavuconazole as primary antifungal prophylaxis against invasive fungal infection (IFI) among immunocompromised patients. Therefore, the purpose of this study was to assess efficacy and breakthrough IFIs of isavuconazole prophylaxis by a pooled analysis of the reported cases of isavuconazole prophylaxis with a comparison of cases of posaconazole delayed-release tablet prophylaxis. Methods Pubmed was searched for English-written articles published up to April 2021. Studies that reported cases of primary antifungal prophylaxis with isavuconazole or posaconazole delayed-release tablet in adults ≥ 18 years were reviewed. Breakthrough IFI was defined as the occurrence of proven or probable IFI while on prophylaxis. Results For overall isavuconazole prophylaxis, a total of 818 courses of prophylaxis was identified from 12 studies. Breakthrough IFIs were noted in 41 patients. The median duration of isavuconazole prophylaxis of these patients before the diagnosis of IFI was 17 days. The most common breakthrough IFI was candidiasis (34.1%), followed by aspergillosis (24.4%) and mucormycosis (12.2%). Sixteen patients died (39.0%). Among patients with hematologic malignancies or hematopoietic stem cell transplantation, isavuconazole prophylaxis (404 courses) was compared with posaconazole delayed-release tablet prophylaxis (1952 courses). The incidence rate of breakthrough IFIs was higher in the cohort of isavuconazole prophylaxis (24 patients of 404 courses) than in the cohort of posaconazole delayed-release tablet prophylaxis (44 patients of 1952 courses). Aspergillosis (40.9%) was the most common breakthrough IFI in the cohort of isavuconazole prophylaxis among patients with hematologic malignancies or hematopoietic stem cell transplantation, followed by candidiasis (27.3%) and mucormycosis (18.2%). Conclusion Although isavuconazole is licensed to treat aspergillosis and mucormycosis, breakthrough IFIs including aspergillosis, mucormycosis, and candidiasis may occur while on isavuconazole prophylaxis. Therefore, further studies are needed to define the benefits and risks of isavuconazole prophylaxis. Disclosures All Authors: No reported disclosures