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Determination of Ultraviolet Radiation Intensity in a ICH Photostability Chamber - 2008

9/24/2012
The purpose of this study was to investigate approaches to determine the near UV radiation exposure in an ICH Q1B Option 2 photostability chamber by quinine actinometry. Different approaches were evaluated and showed considerable variances. All factors must be approached scientifically and standardized for photos

Rapid and Easy Technique for Improving In Vitro Dissolution of a BCS Class II Compound - 2010

9/18/2012
The purpose of this study was to evaluate the use of the hot melt granulation technique for improving dissolution and bioavailability of a poorly soluble API. Coating was achieved by adjusting the spray rate and inlet temperatures. The final formulation was found to be stable.

Quantitative and Miniaturized Assessment of External Lubrication to Reduce Tooling Adhesion in Early Formulation Development - 2008

9/18/2012
The purpose of this study was to assess the effect of externally applied magnesium stearate lubricant on the compression of unlubricated refractory blends with mini-tooling on a development scale rotary tablet press.

Development of Controlled-Release Tablet Formulation Using Hydrophilic Polymer Matrix Systems - 2008

9/18/2012
The purpose of this study was to develop large diameter, non-disintegrating controlled-release tablet formulations using hydrophilic polymer matrix systems for pH sensitive low solubility drugs. The results indicated that interactions of drug, excipients and polymer play an important role.

Development of a Model for Roller Compaction Formulations Based on Tabletability Performance - Part lV: Ibuprofen Blends - 2008

9/18/2012
The purpose of this study was to evaluate the effect of increasing ibuprofen content on the tabletability performance of roller compacted blends as part of a larger study towards development of a model for roller compaction formulations.

Development of a Model for Roller Compaction Formulations Based on Tabletability Performance - Part lll: Naproxen Blends - 2008

9/18/2012
The purpose of this study was to evaluate the effect of increasing naproxen content on the tabletability performance of roller compacted blends as part of a larger study towards development of a model for roller compaction formulations. Compactibility is the dominant factor in determining tabletability in the cas

Development of a Model for Roller Compaction Formulations Based on Tabletability Performance - Part ll: Aspirin Blends - 2008

9/18/2012
The purpose of this study was to evaluate the effect of increasing aspirin content on the tabletability performance of roller compacted blends as part of a larger study towards development of a model for roller compaction formulations.

A Design Space Approach to Process Troubleshooting and Optimization for a Fluid Bed Granulation Process - 2009

9/18/2012
The objective of this study was to demonstrate process optimization using dependent variables that correspond to key process phenomena to define the design space. This approach is an experimentally efficient technique for process development, scale-up, and troubleshooting.

Development and Validation of an HPLC/MS Method for the Determination of Benzalkonium Chloride Residues - 2010

9/18/2012
The purpose of this study was to develop and validate an analytical method for the determination of residual detergent, Benzalkonium Chloride, in samples collected after cleaning of pharmaceutical manufacturing equipment with industrial detergents.

Capsule Cracking Effects During Large-Scale Filling of Hygroscopic Liquid Materials into Hard Gelatin Capsules - 2010

9/18/2012
The purpose of this study was to understand the influence of capsule design, manufacturing scale, storage condition (humidity) and hygroscopicity on cracking of liquid filled hard gelatin capsules (LFHC). This study confirms that liquid filled hard gelatin capsule cracking is associated with capsule design.

An Examination of the Moisture Sorption Characteristics of Nitrofurantoin Monohydrate - 2010

9/18/2012
The purpose of this study was to emphasize the use of dynamic vapour sorption as a tool in understanding the behaviour of crystalline APIs in the presence of moisture, and which experimental set up conditions best help to understand the movement of water/moisture.

Investigation of Leachable Compounds from Components of a Dosing Device and Product Packaging into a Low Dose Solid Oral Dosage Form - 2011

9/18/2012
The purpose of this study was to investigate the source of two unknown impurities (RRT 0.45 and RRT 0.76) detected in a low-strength solid oral dosage form (tablets) packaged in cartridges in a foil pouch under accelerated and long-term storage conditions.

Quantitative and Miniaturized Assessment of Tooling Adhesion - Mapping the Boundary of Lubricant Failure/Effectiveness - 2008

9/18/2012
The purpose of this study was to define the design space for blend lubrication by quick and quantitative tooling adhesion predictions using miniaturized tooling tests. The results may define and predict the design space for processing incoming lots of drugs and excipients.

Development of a Model for Roller Compaction Formulations Based on Tabletability Performance - Part l: Excipient Blends - 2008

9/18/2012
The purpose of this study was to evaluate the effect of lactose monohydrate of the tabletability performance of roller compacted blends a s a preliminary screening study towards development of a model for roller compaction formulations. The flowability based on Carr's Index measurement decreased slightly.

Method Development to Prepare Spray Dry Dispersions for Early Development Compounds Using Statistical Design of Experiments-2011

9/4/2012
The objective of this study was to determine critical process parameters which influence the characteristics of spray dried materials for quick small scale formulation screening using DOE. Different polymers (PVP-K30 in dichloromethane and HPMCAS LF in 2:1 w/w of dichloromethane: methanol) were spray dried at a b

An Alternative Banding Method for HPMC Liquid Fill Hard Shell Capsule-2011

9/4/2012
The objective of this study wast o evaluate the HPMC banding process and morphology using different banding agents, and compare HPMC banding and regular gelatin banding processes. To look for a possible new water based HPMC banding process and banding agent to replace the current alcohol/water based HPMC banding.

Blend Residence Time in a Tablet Press Feeder - 2010

9/18/2012
The purpose of this study was to investigate the over lubrication susceptibility of model folic acid formulations inside a tablet press force feeder and the effects on the physical properties and dissolution performance of the tablets. The results obtained from the study showed that the residence time of a powder

Electrostatic Dry-Powder Functional and Active Coating Using Conventional Pan Coaters - 2008

9/18/2012
The purpose of this study was to develop formulations and methods for functional and active film coating in a conventional pan coater. The results suggest that tablets of various release profiles and satisfactory appearance have been produced by dry powder film coating in conventional equipment.

Novel Drug Delivery Approach to Achieve Zero-order Release Kinetics: Coated Matrix Based Formulation for Freely Soluble Drugs - 2011

9/18/2012
The objective of this study was to achieve the drug release rate which is independent of time and the concentration from a solid oral tablet dosage form. A zero order, pH independent release formulation for a freely water soluble model drug (Buspirone HCL) was developed.

A Novel Technique for Compressing Powder Blends Containing Low Melting Substances and Waxy Materials in a Tablet Dosage Form - 2009

9/18/2012
The objective of this study was to evaluate a novel technique for compressing blends at low temperatures using Vortex Coolers. Processing of low melting APIs or excipients such as solubilizers/bioavailability enhancers into a tablet dosage form has been a challenge.

Development of Oral Fast Disintegrating Tablets Using Direct Compression and Extreme Vertices Method Design of Experiment (DoE) - 2008

9/18/2012
The purpose of this study was to evaluate the development of oral fast disintegrating tablets by conventional direct compression method and statistical design of experiment. Better results were obtained with lower strength than higher strength tablets.

Comparative Study of Manual Dissolution with On-line UV and Fiber Optical Probe Automated Dissolution Systems - 2008

9/18/2012
The purpose of this study was to compare the reliability and reproducibility of manual and automated dissolution-UV methods. Extended-release acetaminophen was selected as the model. This study demonstrated that the fiber optic probe system was preferred over the on-line UV system.

Effect of Granulation Factors on the Compression Behaviour of a Slow Release Polymeric Matrix Formulation - 2009

9/18/2012
The purpose of this study was to investigate the effect of wet granulation factors on the compression behaviour and other physical characteristics of a slow release polymeric matrix formulation. The water quantity used for granulation was the most important contributing factor.

Small Scale Optimization of an Active Formulation Roller Compaction Process Using a True Placebo Design of Experiments (DoE) - 2009

9/18/2012
The purpose of this study was to evaluate the use of a true placebo DoE to create a platform process in which to define a viable active formulation process on a roller compactor. The use of placebo DoE was effective in creating a platform process for active feasibility trials and scale-up using minimal API.

LIBS (Laser Induced Breakdown Spectroscopy) as an At-line Monitor of API Coating Uniformity in a Film Coating Operation - 2009

9/18/2012
The purpose of this work was to study the use of LIBS (Laser Induced Breakdown Spectroscopy) as an in-process monitor for uniformity during an API tablet coating process. In-process measurements were taken up to the coating endpoint, and evaluated to obtain tablet coating thickness and uniformity information.

Enteric Coating of Empty HPMC Capsule Shells Using a Wurster Fluid-Bed Coating Process - 2009

9/18/2012
The purpose of this study was to develop and optimize a Wurster fluid-bed coating process for applying an enteric coating onto empty hypromellose capsule caps and bodies to achieve acid resistance after filling. Coated capsules were manually filled and closed without damage to the coating.

Optimization of Throughput Conditions for Scale-up of a Roller Compacted Product - 2009

9/18/2012
The purpose of this study was to establish the design space and operational conditions for the roller compaction process of a placebo formulation that closely represents a low-dose active formulation. The ribbon density, tensile strength, mean granule size and granule surface area can impact the process.

Optimization of Fast Disintegrating Direct Compression Tablets by Statistical Design - 2009

9/18/2012
The purpose of this study is to further optimize and assess the effect of refining magnesium stearate lubricant, sweetener, hardness and thickness levels on the design of a fast disintegrating formulation by direct compression.

Investigation of Areas of Discoloration on Stability Samples of Pharmaceutical Tablets – A Case Study - 2010

9/18/2012
The purpose of this study was to investigate the root cause and potential mechanism behind the areas of discoloration on stability samples of pharmaceutical tablets. The most likely mechanism of tablet discoloration was related to a dehydration reaction.

Influence of Smooth Roll Surface on Compaction Behavior of Model Formulations - 2010

9/18/2012
The purpose of this study was to understand the roller compaction behavior of different model placebo formulations using smooth rolls and to compare their performance against different roll surfaces. This study clearly demonstrates the differences in throughput.

Cracking Effects Found with Placebo Liquid Formulations Filled into Hard Gelatin Capsules - 2010

9/18/2012
The purpose of this study was to evaluate the incidence of cracking of gelatin capsules filled with commercially viable examples of hygroscopic placebo formulations and low viscosity hydrophobic liquids.

An Alternative Banding Method for HPMC Liquid Fill Hard Shell Capsule - 2011

9/18/2012
The purpose of this study was to evaluate the HPMC banding process and morphology using different banding agents, and compare HPMC banding and regular gelatin banding processes and to look for a possible new water based HPMC banding process and banding agent.

Method Development to Prepare Spray Dry Dispersions for Early Development Compounds Using Statistical Design of Experiments - 2011

9/18/2012
The purpose of this study was to determine critical process parameters which influence the characteristics of spray dried materials for quick small scale formulation screening using DOE. Cconcentration of the spray dry solution can significantly affect the properties.

A Novel Controlled Release Formulation for Orally Disintegrating Tablets Using Ion Exchange Resins - 2011

9/18/2012
The goal of this study was to design a platform technology for a controlled release orally disintegrating tablet (ODT) using cationic ion exchange resins which will facilitate taste masking. Sodium polystyrene sulfonate, USP (AMBERLITETM IRP69) was used as an ion exchange polymer.

A Rapid Vehicle Screen Approach for Formulating Liquid Filled Capsule of a Low Soluble Compound - 2011

9/18/2012
The objective of this study was to enhance the solubility and in-vitro dissolution/bioavailability of a low soluble (0.5 mg/mL) BCS Class II compound (API). A mixture approach enabled selection of excipients and to arrive at an optimal ratio based on the excipient properties.

Investigation of Leachable Compounds from Components of a Dosing Device and Product Packaging into a Low Dose Solid Oral Dosage Form - 2011

9/4/2012
The objective of this study was to investigate the source of two unknown impurities (RRT 0.45 and RRT 0.76) detected in a low-strength solid oral dosage form (tablets) packaged in cartridges in a foil pouch under accelerated and long-term storage conditions.

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