31. March 2017
Abstract Poloxamer 188, a commonly used emulsifying and solubilizing agent, was found to be the cause of crystallization of an investigational drug, AMG 579, from its amorphous solid dispersion at accelerated storage conditions. Investigation of this physical stability issue included thorough characterization of poloxamer 188 at non-ambient conditions. At 40 °C, poloxamer 188 becomes deliquescent above relative humidity of 75%. Upon returning to ambient conditions, the deliquescent poloxamer...
31. March 2017
ABSTRACT: CTwo year look back at the status of the NSF / IPEC / ANSI 363 GMP Standard for Pharmaceutical Excipients. What are we seeing as a certification body including best practices around risk assessment, quality improvement, the role of management and feedback from companies that have worked to meet the requirements of this GMP standard? More Information & Registration
31. March 2017
Abstract The aim of the present study was to establish a novel polymeric excipient for liquid nasal dosage forms exhibiting viscosity increasing properties, improved mucoadhesion and stability towards oxidation in solution.In order to achieve this goal, 2-mercaptonicotinic acid was first coupled to l-cysteine by disulfide exchange reaction and after purification directly attached to the polymeric backbone of xanthan gum by carbodiimide mediated amide bond formation. The resulting conjugate was...
31. March 2017
Abstract The objective of this work was to assess the effect of process parameters of a dosator nozzle machine on the powder bed uniformity of inhalation powders with various characteristics during a low-dose dosator capsule filling process. Three grades of lactose excipients were extensively characterized and filled into size 3 capsules using different dosing chamber lengths (2.5, 5mm), nozzle diameters (1.9, 3.4mm), powder bed heights (5, 10mm) and filling speeds (500, 3000capsules/h).The...
31. March 2017
The majority of today’s new chemi- cal entities are poorly water-soluble. One widely used means of overcom- ing that problem is to develop solid dispersions by mixing at the molecular level the drug candidate into a polymer matrix [1]. Spray drying and hot-melt extrusion (HME) are the most common technologies used to manufacture these amorphous solid dispersions. With spray drying, an organic solvent dissolves the API and polymer, followed by rapid removal of the solvent. With HME, an...
30. March 2017
Abstract Aim The efficacy of self-assembling peptide P11-4 to regenerate enamel in natural early caries lesions was evaluated over 50 days by photothermal radiometry and luminescence using The Canary System (CS) and The Canary Lab (CL). Methods Baseline readings for sound and carious sites on smooth surfaces of extracted teeth were obtained by scanning with CS and CL. Teeth were then randomly assigned to a treatment group (TG, treated with P11-4), a placebo group (PG, same vehicle as treatment...
30. March 2017
Abstract Chitin is one of the most abundant natural polymers in the world and is used for the production of chitosan by deacetylation. Chitosan is nontoxic and biodegradable and, therefore, can be used as a biomaterial and for the construction of drug delivery systems. Nevertheless, the poor solubility of chitosan in neutral or alkalinized media has restricted its applications in the pharmaceutical and biomedical fields. Chitosan can be easily carboxymethylated to improve its solubility in...
30. March 2017
Abstract Biopolymers are able to address a wide variety of medical concerns from chronic wounds to stem cell cultivation to antibacterial and antifouling applications. They are non-toxic, biodegradable, and biocompatible, making them ideal candidates for creating green materials for biological applications. In this thesis, we cover the synthesis of two novel materials from the biopolymers, chitosan and pectin. Chitosan is a biocompatible antibacterial polycation and pectin is an...
30. March 2017
Aim: First extensive reformulation of clofazimine (CLZ) in nanoporous silica particles (NSPs) for tackling antibiotic-resistant tuberculosis (TB) infections. Materials & methods: Solid-state characterization of several CLZ-encapsulated NSP formulations was followed by in vitro drug solubility, Caco-2 intestinal cells drug permeability and TB antibacterial activity. Results: NSPs stabilize the amorphous state of CLZ (shelf stability >6 months) and dramatically increase the drug solubility...
30. March 2017
The topical treatment of extraocular or intraocular diseases, especially by eye drops, is the best accepted by patients. Treatment with eye drops, however, poses the issue of a poor drug bioavailability because the precorneal area, i. e., the site of drug action/absorption, is rapidly cleared of drugs by protective mechanisms of the eye, such as blinking, basal and reflex tearing, and nasolachrymal drainage. This implies the need of frequent instillations, and hence, the risk of side effects....