by Innopharmatechnology & Glatt @ PMEC India 2017 Learn about the latest Process Analytical Technology (PAT) technical and application developments for in-line PSD and Moisture measurement in fluid bed batch and continuous powder processes. More
The objective of the present study was to develop rectal mucoadhesive hydrogels loaded with Tolmetin Sodium, a non-steroidal anti-inflammatory drug, for prolonged duration of action and increased bioavailability. Fourteen formulae were prepared with different types and concentrations of polymers as hydroxypropylmethyl cellulose, hydroxylethyl cellulose, carboxymethyl cellulose and sodium alginate. Each formulation contain Tolmetin Sodium equivalent to 5% w/w active drug. The effect of the...
The behaviour of proteins (β-lactoglobulin (βlg) and soy protein isolate (SPI)) and a surface active polysaccharide (hydroxypropylmethylcellulose, HPMC) o/w interfacial films under simulated gastrointestinal conditions using the interfacial tensiometer Octopus were compared and related to the performance of the emulsions (using the same emulsifiers) under in vitro digestion. The evolution of interfacial tension (γ) was used to investigate the effect of gastrointestinal fluids on o/w...
The aim of the present investigation is to produce rapidly disintegrating laminar extrudates for delivering ibuprofen in the mouth of paediatric patients. is laminar shape is particularly convenient for drug delivering in the mouth and can be easily cut in cut in di erent sizes allowing for a convenient adjustment of the drug dose depending on the age of the patient. Due to the fact that in paediatric formulations, the selection of the excipients is always a challenging issue and the reduction...
Pharmaceutical excipients are substances other than the pharmacologically dynamic medication or prodrug which are incorporate into the assembling procedure or are contained in a completed pharmaceutical item measurements form.
Three versatile formulations (F1, F2, and F3) of orodispersible films (ODFs) containing donepezil hydrochloride were prepared from cellulose derivatives by solvent casting technique for the treatment of Alzheimer’s disease.
A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions.
Making a case for GMP certification of an excipient
manufacturer should be a straightforward
exercise since the benefits appear so clear cut and
regulatory guidance in the EU underscores the
value of certification. Specifically, Chapter 3 of the
EMA Guidance on formalized risk assessments to
determine the appropriate GMP for a pharmaceutical
excipient states that “certification of quality systems
and/or GMP by the excipient manufacturer and the
standards against which these have been granted...
Poor water-solubility remains a typical property of drug candidates in pharmaceutical development pipelines today. Various processes have been developed to increase the solubility, dissolution rate, and bioavailability of these active ingredients belonging to biopharmaceutical classification system (BCS) II and IV classifications. Since the early 2000s, nanocrystal delivery and amorphous solid dispersions are more established techniques to overcome the limitations of poorly-water soluble drugs..
The purpose of this study was to explore poly(vinylpyrrolidone-co-vinyl acetate) (PVP VA64) as a novel release-modifier to tailor the drug release from ethylcellulose (EC)-based mini-matrices prepared via hot melt extrusion (HME). Quetiapine fumarate (QF) was selected as model drug. QF/EC/PVP VA64 mini-matrices were extruded with 30% drug loading.