October 9th 2024
Through the global partnership, Colorcon will exclusively represent LOTTE’s AnyCoat Hypromellose products.
Scale Up of a Granulation Phenomenon
October 2nd 2005Although agitation improves drying efficiency and ensures uniformity of the final dry material, it can also affect the physical properties of the product as it dries. This study evaluates the effect of scale up and equipment selection on an active ingredient undergoing granulation during the drying process.
Carrageenans: Analysis of Tablet Formation and Properties (Part II)
September 1st 2005The tablet formation of six different carrageenans was analysed by 3D modelling, Heckel analysis, the pressure–time function and energy calculations. It was found that the fibres experienced plastic deformation, which was accompanied by a great deal of elasticity. Measurement of elastic recovery in dependence on maximum relative density and time showed that relaxation is completed a considerable amount of time after tabletting. Shrinking of the fibres occurred in parallel with elastic recovery as a result of the reorganization of the fibre structure. The tabletting behaviour of carrageenans makes them suitable for the soft tabletting of pressure sensitive materials.
The Role of Reverse Engineering in the Development of Generic Formulations
August 2nd 2005Being the first to gain the most is a fundamental principle in the generics business because several companies compete to create generics of successful products going off patent. For a generics company to maintain revenue growth in a market in which product prices continue to fall, it must secure a continuous flow of new products, with quality and speed to market being key drivers. Thus, generics companies must be highly skilled in product and process development (1), the generics business, and achieving bioequivalence-the most critical development area.
Carrageenans: Analysis of Tablet Formation and Properties
August 1st 2005The aim of this study was to analyse the process of tablet formation and the properties of the final tablets for six different carrageenans. The carrageenans used were based on the basic types of ?-, ?- and ?-carrageenan. Microcrystalline cellulose was used for comparison. Determination of material properties, compression analysis and tablet properties were described. Water content, particle size and morphology, glass transition temperature, and crystallinity were studied. The results show that the carrageenans are predominantly amorphous fibres, which are in the rubbery state during tabletting.
Current Thoughts on Critical Process Parameters and API Synthesis
July 2nd 2005A stepwise, process risk-assessment approach can facilitate the identification and understanding of critical process parameters, quality attributes, and in-process controls. This approach can lead to more use of science- and risk-based regulatory practices to simplify the regulatory requirements for changes to synthetic processes and to support the underlying quality systems that ensure compliance.
Polymers for Controlled Release Formulation Follows FunctionMaribel Rios
June 2nd 2005Once considered mainly an afterthought in a company's lifecycle-management strategy, controlled-release dosage forms are now positioned at the forefront of many formulation strategies. In contrast to drug discovery, formulation work focuses not only on the intricacies of the active pharmaceutical ingredient (API), but also on fine-tuning the excipients, the release profile, and the delivery mechanism to provide optimal therapeutic benefit. Because of their wide range of applications and functionalities, especially in controlled-release therapies, polymers are among the most widely used excipients.
Use of a Modified Twin-Screw Extruder to Develop a High-Strength Tablet Dosage Form
June 2nd 2005Wet granulation is a size-enlargement process in which a liquid is used to achieve the agglomeration of solid particles. Agglomeration improves particles' tableting properties by rendering them free-flowing, nonsegregating, and suitable for compression (1).
X-ray Microtomography of Solid Dosage Forms
April 2nd 2005X-ray microtomography has great potential for improving the understanding of the structural features of solid dosage forms and the changes in those features during manufacturing, handling, and storage.This article describes the basic principles of the technique and provides examples of its potential applications.
Establishing Target Fills for Semisolid and Liquid Dosage Forms
April 2nd 2005To meet the requirements of the USP ^755& Minimum Fill and ^698& Deliverable Volume tests, target fill levels greater than 100% must be established.This article proposes a criterion for establishing an appropriate target fill level such that a sample will have a 95% probability of passing these USP tests at 95% confidence.
X-ray Microtomography of Solid Dosage Forms
April 1st 2005X-ray microtomography has great potential for improving the understanding of the structural features of solid dosage forms and the changes in those features during manufacturing, handling, and storage. This article describes the basic principles of the technique and provides examples of its potential applications.
Using Extrusion-Spheronization to Develop Controlled-Release Formulations of Azithromycin
February 2nd 2005Extrusion-spheronization and pellet compression are effective means of developing first-order kinetic, controlled-release drug delivery systems of azithromycin (AZI). The authors prepared, evaluated, and optimized AZI formulations and assessed the stability of the selected formulation under accelerated storage conditions.
The Preparation and Evaluation of Albendazole Microspheres for Colonic Delivery
December 2nd 2004Microspheres of Eudragit RL were developed for colonic delivery of albendazole. The effects of polymer concentration, stirring rate, and concentration of emulsifier on particle size and drug loading were studied. A comparative in vitro drug release study of the optimized formulation was carried out.