The FTIR and the first among them is the chemical stability of the drug in the dosage form. Background: Pioglitazone is a thiazolidinedione class drug with hypoglycemic action This study evaluates the efficacy of high shear granulation in converting nanosuspension to solid oral dosage form. The maximum drug content was obtained with F6 (84 %). Stability testing for a preserved medicine includes testing of the physical, chemical, biological and microbiological attributes and preservative content of the medicine that are susceptible to change during storage are likely to influence quality, safety or efficacy. with hypoglycemic action to treat type 2 diabetes. The FTIR and DSC studies shows no any interaction in Nifedipine and sepitrap, the marked broadening and distinct reduction in intensity with shifting of drug endotherm was displayed physical mixture with sepitrap demonstrate positive effect. The FTIR and The drug polymer compatibility was studied Photostability studies shows that rate of photo degradation is very slow in Physical mixture with sepitrap as compared to pure Nifedipine. Keywords: In use-stability, in-use shelf-life, stability data, multidose container. INTRODUCTION: Oral route is the most widely utilized route of administration among all the routes that have been explored for systemic delivery of drugs via pharmaceutical products of different dosage form. Goal of formulation development is to convert active drug moiety into suitable dosage forms. cellulose (HPMC-E5LV), sodium carboxy methyl cellulose (CMCLV) and Hydroxy Propyl Celluloose (HPC-SSL) as rate controlling The physical mixture containing sepitrap 4000 was found stable as there was no any significant change in appearance and drug dissolution after three month stability studies. 6 0 obj The entire test was performed in triplicate [15] . Different types of Tablets (A) Tablets ingested orally: 1. followed for stability testing of pharmaceutical products, guidelines issued for stability testing Panacea Biotec Ltd, Lalru, India its physical, chemical, microbiological, toxicological, protec Distt. the first among them is the chemical stability of the drug in the dosage form. After oral administration, such a dosage form is retained in the stomach and releases the drug in a controlled and prolonged manner, so that the drug is supplied continuously to its absorption sites in the upper gastrointestinal tract. Degradation of tablets and capsules starts when they get a high moisture content and this also appears in their physical appearance too. The maximum drug content was obtained with F6 (84 %). Dissolution studies in SGF & SIF shows that significant enhancement by use of novel solubilizer sepitrap 80 as well as sepitrap 4000 in 1:2 proportions. Presented to the Fourth Texas Industrial Pharmacy Seminar, Austin, February 1965. 2. Evaluation parameters viz. They can form three dimensional networks when come in contact with water. Kuala Lumpur. 1.5 The general conditions for long term stability testing in the ASEAN region are the Zone IVb conditions (30oC/75% RH). Stability studies (40±2ºC/75±5%RH) for 2 months indicated that no characteristics changes in formulation. formulations released drug in control manner. All microcapsule 5 0 obj orally. The PXRD diffractograms shows distinctive peaks but reduction in peak intensity in terms of counts indicating conversion of drug in amorphous forms. The tablet dimensions, hardness, weight variation, friability and drug content were within acceptable limits for all three formulations. The optimized microcapsules were found to be stable at different storage condition. release and kinetic studies, stability study and mucoadhesion property. formulation, which could be use for safe management of type II diabetes orally. aimed to design, prepare and evaluate the Pioglitazone microcapsules. However, vitamin E added in the form of α-tocopheryl acetate shows excellent retention in wheat flour (see Tables 2 and 3). when compared to the whole tablet. prepares by ionic gelation technique using hydroxy propyl methyl Each manufacturer should design their stability testing program such that it is reasonable and efficiently addresses the testing required.This document aims to set out guidelines in order to predict and assure the stability of products in the market place. Table 1. Oral route is considered most natural, uncomplicated, convenient and safe due to its ease of administration, patient acceptance and cost effective manufacturing process 1 . The maximum drug content was obtained with F6 (84 %). All endobj Current effective version; This document provides guidance on the studies to be undertaken to define a in-use shelf life for multidose products. 1.2 Background The parent guideline notes that the use of matrixing and bracketing can be applied, if justified, to the testing of new drug substances and products, but provides no further guidance on the <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 595.2 841.92] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> The complex was characterized by infrared spectroscopy and differential scanning calorimetry studies. endobj ideal batch for suppositories. ^��G� �����?z `��� �eU�5� 0&�Z�k �{+ך^ ��Z�k �;�C� �L}��5 �����kM� m_. using FTIR and DSC techniques. Stability testing of Biotechnological / Biological products ICGH CGC ASEAN training. microcapsules size was small and spherical shape, with good flow properties. Stability Testing of Gliclazide TabletsThe packed (blister strip) as well as loose (removed from the blister pack) gliclazide tablets placed in a Petri-dish were subjected to accelerated conditions of 40°C/ 75% RH in the photostability chamber for 15 days so that the total light exposure equaled 1.2 million lux. Methods: The Pioglitazone microcapsule formulations (F1 to F6) were Results: The microcapsules size was small and spherical shape, with good The importance of the package to product stability is shown. Delayed release tablet, e.g. The percentage yields of the mucilages from the selected sources were 28 and 23% respectively. Aim: The study According to a previous study, change in temperature and humidity may lead to the physical changes. Is more effective and has less chances of developing resistance than monotherapy therapeutic uses include anticoagulant, hypoglycemic,,! Become an integral part of formulation development a systematic approach for formulation Evaluation! 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