Intersupplier and interlot variability in hydroxypropyl celluloses: implications for theophylline release from matrix tablets

Fatty Acid and Water-Soluble Polymer-Based Controlled Release Drug Delivery System

“…A controlled release drug delivery system based only on the polymers has inherent problems such as lot-to-lot variability of polymers resulting in nonreproducible product performance. 9,10 Moreover, several of such approaches have been patented and require licensing of such technologies from the patent holders, thus increasing the product cost. To circumvent these problems, a novel approach has been invented to formulate a controlled release drug delivery system.…”

Rheological Evaluation of Inter-grade and Inter-batch Variability of Sodium Alginate

“…Solid-state 13 C NMR spectra were acquired using a Chemagnetics CMX-300 spectrometer (Varian, Inc., Fort Collins, CO) operating at approximately 75 MHz for 13 C. Chemagnetics double-resonance probes equipped with Revolution NMR 7-mm spinning modules (Revolution NMR, LLC, Fort Collins, CO) were used to acquire all spectra. Samples were packed into zirconia rotors and sealed with Teflon end-caps.…”

“…Since these variations can markedly affect the processability or performance of a sodium alginate-containing pharmaceutical product (8,9), adherence to the USP-NF monograph may not ensure the interchangeability of sodium alginates from different sources or even various batches from the same manufacturer. Previous studies have shown that the inter-manufacturer and/or inter-batch (lot) variability of excipients can exert a significant effect on the performance of the final formulations, even though these excipients meet the pharmacopeial specifications (10)(11)(12)(13)(14). Since pharmacopeial specifications focus on identity, purity, and safety, they are not guarantors of excipient performance.…”

Excipient Variability and Its Impact on Dosage Form Functionality

“…Differences in the particle size were found to be responsible for the interlot and intermanufacturer variability observed in dicalcium phosphate dihydrate. Batch‐to‐batch differences in the excipient properties has been shown to influence a broad range of excipient functionalities used in the solid, semisolid, and liquid dosage formulations . Alvarez‐Lorenzo et al compared the physicochemical properties of three lots of high‐viscosity hydroxypropylcellulose (HPC).…”

“…Batch‐to‐batch differences in the excipient properties has been shown to influence a broad range of excipient functionalities used in the solid, semisolid, and liquid dosage formulations . Alvarez‐Lorenzo et al compared the physicochemical properties of three lots of high‐viscosity hydroxypropylcellulose (HPC). The results showed clear differences in molecular weight, molecular structure, particle size distribution, particle shape, and water affinity for HPC lots from the same supplier, as well as lots from different suppliers.…”