Aqualon: Sodium Carboxymethylcellulose and its attributes in Ophthalmic formulations
Enforcement Report - Week of March 30, 2022
Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the launch of a new over-the-counter (OTC) artificial tear formulation, REFRESH® REPAIR Lubricant Eye Drops. The first and only artificial tear in the U.S. formulated with carboxymethylcellulose (CMC), hyaluronic acid (HA, an inactive ingredient), and osmoprotectants, REFRESH® REPAIR is the latest addition to the REFRESH® portfolio, the number one doctor-recommended brand of artificial tears.
Enforcement Report - Week of May 24, 2017
The colon is a promising site for drug targeting owing to its long transit time and mild proteolytic activity. The aim of this study was to prepare new low methoxy amidated pectin/NaCMC microspheres cross-linked by a mixture of Zn2+ and Al3+ ions and test their potential for colonic targeting of progesterone. A 24 factorial design was carried out to optimize the preparation conditions. High drug entrapment efficiency (82–99%) was obtained and it increased with increasing drug concentration but decreased with increasing polymer concentration. Drug release rate was directly proportional to the microsphere drug content and inversely related to Al3+ ion concentration. Drug release was minimal during the first 3 h but was significantly improved in the presence of 1% rat caecal contents, confirming the microsphere potential for colonic delivery. The microspheres achieved >2.3-fold enhancement of colonic progesterone permeability. These results confirm the viability of the produced microspheres as colon-targeted drug delivery vehicle.
Microspheres of meclozine hydrochloride (MCZ HCl) were formulated in order to prolong the residence time at the absorption site by intimate contact with the mucous membrane. The microspheres were prepared by oriface-ionotropic gelation method using bioadhesive polymers such as xanthan, sodium, carboxy methyl cellulose (Na- CMC) and hydroxy propyl methylcellulose (HPMC k15) in combination with different ratio of sodium alginate. Totally nine different formulations of MCZ HCl were prepared by using the above polymers. The microspheres were evaluated for percentage yield, entrapment efficiency, particle size analysis, surface morphology (scanning electron microscopy), differential scanning calorimetry (DSC), swelling index, drug content and in-vitro dissolution study. The relative bioavailability of the optimized microspheres was compared with commercially available product after oral administration on healthy human volunteers using a randomized, cross-over design.
FDA warns vs. 5 unregistered drug products
Attix Pharmaceuticals Recalls Hundreds of APIs From the U.S.