Comparison of in vitro screening methods for evaluating the effects of pharmaceutical excipients on membrane permeability
The effects of pharmaceutical excipients on intestinal drug absorption have been highlighted and careful excipient selection is required to develop biologically equivalent formulations. This study aimed to evaluate the effects of excipients on drug permeability and compare the characteristics of in vitro screening methods. Three in vitro models,…
Surfactants in Biopharmaceuticals – AAPS Blog
13. April 2016
By Hanns-Christian Mahler and Satish K. Singh
Polysorbates (PS) (or surfactants in general) are commonly added to biopharmaceuticals as stabilizers against interface-mediated stresses. They are recognized…
Rapid Formulation Development for Monoclonal Antibodies
13. April 2016 Monoclonal antibodies (MAbs) are at the focal point of biologics development. Many of the best-selling drugs are therapeutic MAbs or related proteins (1–2).…
Draft guideline on the sterilisation of the medicinal product, active substance, excipient and…
13. April 2016
This guideline provides guidance on the documentation expected for sterile products in the quality dossier for a marketing authorisation application or a variation application for a medicinal product,…
Comparability Protocols -Chemistry, Manufacturing, andControls Informationfor New Animal Drugs
12. April 2016 Guidance for Industry Submit comments on this guidance at any time. Submit electronic comments on the guidance to http://www.regulations.gov. Submit…
Calcium pectinate gel beads obtained from callus cultures pectins as promising systems for…
12. April 2016 Highlights • We develop calcium pectinate gel beads using pectins from the cell walls of callus cultures. • The bead systems from callus…
In-line PAT solutions for understanding and controlling fluidised bed granulation (FBG) processes
12. April 2016 Determining CPP’s in DoE using Eyecon particle characteriser and Multieye Multipoint NIR Application note: In-line PAT solutions for understanding and…
A Novel Use of Friability Testing for Characterising Ribbon Milling Behaviour
11. April 2016 Dry granulation using roll compaction (DGRC) becomes increasingly adopted in the pharmaceutical industry due to its unique advantage of not requiring liquid…
Impact of polymer type on bioperformance and physical stability of hot melt extruded formulations of…
11. April 2016 Amorphous solid dispersion formulations have been widely used to enhance bioavailability of poorly soluble drugs. In these formulations, polymer is included…
Comparative Study Between Different Ready-Made Orally Disintegrating Platforms for the Formulation…
09. April 2016
Sumatriptan succinate (SS) is a selective serotonin receptor agonist used for the treatment of migraine attacks, suffering from extensive first-pass metabolism and low oral bioavailability (∼14%). The aim of…
INT-006 Age – appropriateness of formulations of cardiovascular medicines for neonates
09. April 2016 Background Appropriate drug formulations are essential for efficacy and safety of medicine. Purpose Our aim was to assess the extent of use of…
Effects of Permeation Enhancers on Flufenamic Acid Delivery in Ex Vivo Human Skin by Confocal Raman…
09. April 2016 For effective topical delivery, a drug must cross the stratum corneum (SC) barrier into viable tissue. The use of permeation enhancers is a widespread…
Using containerless methods to develop Amorphous pharmaceuticals
09. April 2016 Background Many pipeline drugs have low solubility in their crystalline state and require compounding in special dosage forms to increase bioavailability…
Preparation and Evaluation of Solid Dispersion Tablets by a Simple and Manufacturable Wet…
09. April 2016
The aim of this study was to prepare and evaluate solid dispersion tablets containing a poorly water-soluble drug using porous calcium silicate (PCS) by a wet granulation method. Nifedipine (NIF)…
CP-099 Oral dosage form administration practice in children under 6 years of age: A survey study of…
09. April 2016 Abstract Background Administration of oral formulations in children is challenging for paediatric nurses who face these matters in their daily practice.…
Formulation Development of Floating Microspheres of Cefditoren Pivoxel by 32 Factorial Design and in…
08. April 2016
Aim: The main objective of the present research work was to develop floating microspheres of cefditoren pivoxel (CP) to provide the delivery of the drug at a sustained rate.
Materials and Methods:…
IPI and Pfizer Launch Multiparticulate Device Challenge
08. April 2016 Program Seeks Innovative Proposals for Dispensing Pediatric Drug Formulations IPI is thrilled to announce the launch of the Pediatric Device Challenge, run…
FORMULATION OF VENLAFAXINE HCL AS GASTRO-RETENTIVE TABLET USINGDIFFERENT CONCENTRATION OF HPMC AND…
07. April 2016 FORMULATION OF VENLAFAXINE HCL AS GASTRO-RETENTIVE TABLET USINGDIFFERENT CONCENTRATION OF HPMC AND ITS EVALUATION The oral route is considered as the most…
Development and Evaluation of Chitosan and Aloe Vera Gel Mucilage Interpolymer Complex-Based…
07. April 2016 Aim: To develop and evaluate interpolymer complex based buccal mucoadhesive films of Tramadol Hydrochloride. The interpolymer complex was prepared by using…
On the exfoliating polymeric cellular dosage forms for immediate drug release
07. April 2016 The most prevalent pharmaceutical dosage forms at present––the oral immediate-release tablets and capsules––are granular solids. Though effective in releasing…
Development of a controlled release formulation by continuous twin screw granulation: Influence of…
06. April 2016 The aim of this study was to evaluate the potential of twin screw granulation for the continuous production of controlled release formulations with…
A MALLEABLE TECHNIQUE FOR FUTURE COATING PROCESS–SOLVENTLESS COATING
06. April 2016 Coatings are a vital part in the formulation of pharmaceutical dosage form to attain grander aesthetic quality, physical and chemical protection for the drugs…
BASF extends excipient range with ‘dust-free’ coating alternative
06. April 2016 BASF has expanded its Kollicoat range of polymer excipients with a product dust-free alternative to enteric coatings. More…
Oasmia Pharmaceutical Reports Positive Clinical Study Results for Proprietary XR17 Nanotechnology
06. April 2016 New York, April 05, 2016 --- Oasmia Pharmaceutical AB (NASDAQ: OASM), a developer of a new generation of drugs within human and veterinary oncology, today…
Why material compressibility assessments are essential to tablet drug development and manufacture
06. April 2016 The compressibility of pharmaceutical materials is a critical quality attribute of a tablet that determines the force needed to make the tablet. This in turn…
How to formulate tablets on a small scale using the Gamlen Tablet Press
06. April 2016 Quality by Design (QbD) is a new pharmaceutical development paradigm in which products are designed to take account of the disease and its impact on the…
Navigating the human gastrointestinal tract for oral drug delivery: Uncharted waters and new…
05. April 2016 Many concepts of oral drug delivery are based on our comprehension of human gastrointestinal physiology. Unfortunately, we tend to oversimplify the complex…
Efficient production of nanoparticle-loaded orodispersible films by process integration in a stirred…
04. August 2016 Abstract Orodispersible films possess a great potential as a versatile platform for nanoparticle-loaded oral dosage forms. In this case, poorly…
Hydrophobic polymers for orodispersible films: a quality by design approach
04. August 2016 Objectives: To develop orodispersible films (ODF) based on hydrophobic polymers with higher stability to ordinary environmental humidity conditions without…
Polymeric microcontainers improve oral bioavailability of furosemide
03. April 2016
Microcontainers with an inner diameter of 223 μm are fabricated using the polymer SU-8, and evaluated in vitro, in situ and in vivo for their application as an advanced oral drug delivery system for the…
Assessment of Pregelatinized Sorghum and Maize Starches as Superior Multi-functional Excipients
02. April 2016 Research exploring pharmaceutical applications of native sorghum and maize crops is needed to improve their economic competitiveness. This work assesses…
Pediatric Study Plans – Draft Guidance FDA
02. April 2016 Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans…
The effect of methacrylation on the behavior of Gum Arabic as pH-responsive matrix for…
01. April 2016 Hydrogels of a natural polysaccharide composed of Gum Arabic (GA) are appropriate materials for drug delivery, since they are water soluble, nontoxic and…
Improving oral bioavailability of acyclovir using nanoparticulates of thiolated xyloglucan
01. April 2016 Acyclovir a BCS class III drug exhibits poor bioavailability due to limited permeability. The intention of this research work was to formulate and…
SOLUBILITY SYMPOSIUM – DOW
01. April 2016 APRIL 27, 2016 - ZURICH, SWITZERLAND SOLUBILITY SYMPOSIUM Dow Pharma Solutions is bringing the brightest and best in the industry…