Determination of drug, excipients and coating distribution in pharmaceutical tablets using NIR-CI
نویسندگان
چکیده
The growing interest of the pharmaceutical industry in Near Infrared-Chemical Imaging (NIR-CI) is a result of its high usefulness for quality control analyses of drugs throughout their production process (particularly of its non-destructive nature and expeditious data acquisition). In this work, the concentration and distribution of the major and minor components of pharmaceutical tablets are determined and the spatial distribution from the internal and external sides has been obtained. In addition, the same NIR-CI allowed the coating thickness and its surface distribution to be quantified. Images were processed to extract the target data and calibration models constructed using the Partial Least Squares (PLS) algorithms. The concentrations of Active Pharmaceutical Ingredient (API) and excipients obtained for uncoated cores were essentially identical to the nominal values of the pharmaceutical formulation. But the predictive ability of the calibration models applied to the coated tablets decreased as the coating thickness increased.
منابع مشابه
Quality Control and Standardization of Rabeprazole Tablets
Rabeprazole sodium is a new stable pharmaceutical composition developed by us in tablet form, consisting of rabeprazole sodium as active ingredient, excipients, a separating layer and enteric coating. The manufacturing method involves pressing with preliminary wet granulation. In this work, a method was developed for the quantitative determination of rabeprazole sodium in tablets with simultane...
متن کاملAnalysis of sustained-release tablet film coats using terahertz pulsed imaging.
The coating quality of a batch of lab-scale, sustained-release coated tablets was analysed by terahertz pulsed imaging (TPI). Terahertz radiation (2 to 120 cm(-1)) is particularly interesting for coating analysis as it has the capability to penetrate through most pharmaceutical excipients, and hence allows non-destructive coating analysis. Terahertz pulsed spectroscopy (TPS) was employed for th...
متن کاملThe Effect of Formulation Variables on the Release Kinetics of Paracetamol Tablet Formulations.
Aim: The objective of this work was to study the effects of formulation variables on the release kinetics of paracetamol tablet formulation. Materials and Methods: Paracetamol tablets were formulated using wet granulation (WG) and direct compression (DC) using two predetermined pressures. Avicel, dicalcium phosphate (DCP) and pregelatinized starch (PGS) were used as directly compressible...
متن کاملبررسی پایداری فیزیکی حالت جامد و سازگاری پیروکسیکام با مواد جانبی قرصها توسط روشهای فیزیکوشیمیایی
Background and purpose: The pharmaceutical excipients can be incompatible with drug or other excipients. Thus, for each material, compatibility with formulation components and packaging materials should be examined. The dissolution of a drug has an important role in its bioavailability. Any change in the physico-chemical properties can result in changes in the drug release, and furthermore in i...
متن کاملThe Effects of Lactose, Microcrystalline Cellulose and Dicalcium Phosphate on Swelling and Erosion of Compressed HPMC Matrix Tablets: Texture Analyzer
This paper reviews the use of texture analysis in studying the performance of hydrophilic matrices of highly soluble drugs and different types of excipients (i.e. water-soluble, water-insoluble and swellable, and water insoluble and non-swellable). Tablets were prepared by direct compression, and their swelling and erosion in presence of these different excipients were assessed with the help of...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
دوره 2 شماره
صفحات -
تاریخ انتشار 2012