08. August 2018
The main purpose of this study was to investigate the influence of ethylcellulose (EC) coating and curing conditions on the quality attributes of pharmaceutical pellets prepared using a quality by design (QbD) approach. The drug release rate of methimazole, a freely soluble model drug, was evaluated extensively together with the mechanical strength and true density of the coated pellets. Moreover, the thermal and spectroscopic properties, as well as the surface characteristics were studied...
07. July 2018
In this study, a process map was developed in an effort to improve the understanding of dry granulation of pharmaceutical excipients by roll compaction process, and to implement the quality-by-design (QbD) approach. Through development of the process map, a correlation was made between the critical process parameters (roll pressure, screw speed), and critical quality attributes (density of ribbons and granule size). This method reduces development time, quantity of materials required and cost....
02. July 2018
The aim of this study was to develop self-nanoemulsifying drug delivery system (SNEDDS) of bosentan using quality by design (QBD) approach with better bioavailability. The major component of the formulation vis-à-vis lipid (Capmul MCM), surfactant (LABRASOL) and co-surfactant (PEG 600) were selected on the basis of saturation solubility. Mixture of LABRASOL and PEG 600 in the ratio of 1:1 showed better nano emulsifying region as depicted by pseudo ternary phase diagram. The optimum mixture of...
17. May 2018
Current in vitro disintegration methods for polymeric films are qualitative and introduce significant user bias. The goal of these studies is to develop a novel, quantitative disintegration technique which can be used to characterize polymeric films in vitro. Methods A method was developed using a Texture Analyzer instrument to evaluate film disintegration. Solvent-casted, clinically advanced, anti-HIV, vaginal films as well as marketed vaginal films were used throughout these studies. Method...
13. November 2017
Parenteral administration of Busulfan (BU) conquers the bioavailability and biovariability related issues of oral BU by maintaining the plasma drug concentration in therapeutic range with minimal fluctuations thereby significantly reducing the side effects. Busulfex® is the only commercially available parenteral formulation of BU composed of organic solvents N, N-dimethylacetamide and polyethylene glycol 400. Since, BU is highly susceptible to hydrolytic degradation; Busulfex® has poor...
13. October 2017
Purpose Lubrication is critical in pharmaceutical manufacturing of solid dosage forms. The purpose of this paper is to systematically compare and correlate the lubrication effect of two devices, a controlled shear system and a Resonant Acoustic Mixer, on the flow properties of pharmaceutical blends. Method A model formulation was selected. Full factorial designs were conducted to examine the effect of the total strain (or total energy) and the shear rate (or power) on the powder blend flow...
02. September 2017
Abstract Capping is a common problem in the manufacture of some types of tablets and unless resolved, the tableting process cannot proceed. Hence, all factors that can help to lessen the likelihood of capping without unnecessarily reduce turret speed and/or compaction force would be tenable. This study investigated the influence of tablet punch configuration on mitigation of tablet capping. Tablets were prepared from high-dose paracetamol-potato starch granules in a rotary tablet press with...
05. July 2017
The current regulatory environment based on the ICH guidelines encourages a systematic and science-based approach in the pharmaceutical development, required by the “Quality by design” concept.
10. April 2017
Abstract The improvements in healthcare systems and the advent of the precision medicine initiative have created the need to develop more innovative manufacturing methods for the delivery and production of individualized dosing and personalized treatments. In accordance with the changes observed in healthcare systems towards more innovative therapies, this paper presents dropwise additive manufacturing of pharmaceutical products (DAMPP) for small scale, distributed manufacturing of...
22. March 2017
Abstract The purpose of this study is to characterize controlled release matrix tablets of captopril and to find out the physicochemical properties that have an effect on the mucoadhesion process. The hydrophilic matrix tablets contain captopril, microcrystalline cellulose, barium sulfate, ascorbic acid, ethylcellulose N100, hydroxypropylmethylcellulose K15M, talc, magnesium stearate and colloidal silicon dioxide. The physicochemical properties of the formulations have been characterized using...