Journal ArticleDOI
Applications of thermal analysis and coupled techniques in pharmaceutical industry
TLDR
The current use of thermal analysis and combined techniques in research and development and in production is reviewed and the advantage of commercially coupled techniques to thermogravimetry is emphasized with some examples.Abstract:
Thermal analysis methods are well-established techniques in research laboratories of pharmaceutical industry. The robustness and sensitivity of instrumentation, the introduction of automation and of reliable software according to the industrial needs widened considerably the areas of applications inthe last decade. Calibration of instruments and validation of results follow the state of the art of cGMP as for other analytical techniques. Thermal analysis techniques are especially useful for the study of the behavior of the poly-phasic systems drug substances and excipients and find a unique place for new delivery systems. Since change of temperature and moisture occur by processing and storage, changes of the solid state may have a considerable effect on activity, toxicity and stability of compounds. Current requirements of the International Conference of Harmonisation for the characterization and the quantitation of polymorphism in new entities re-enforce the position of thermal analysis techniques. This challenging task needs the use of complementary methods. Combined techniques and microcalorimetry demonstrate their advantages. This article reviews the current use of thermal analysis and combined techniques in research and development and in production. The advantage of commercially coupled techniques to thermogravimetry is emphasized with some examples.read more
Citations
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Journal ArticleDOI
Dual-purpose vardenafil hydrochloride/dapoxetine hydrochloride orodispersible tablets: in vitro formulation/evaluation, stability study and in vivo comparative pharmacokinetic study in healthy human subjects.
TL;DR: Gelatin as a matrix former with N-methylpyrrolidone as a solubilizer in VH/DH ODTs improved the dissolution rate and extent of release of VH and DH with 100% of drug being dissolved after 15 min.
Journal ArticleDOI
Peptoid microsphere coatings: The effects of helicity, temperature, pH, and ionic strength.
TL;DR: The effects of various conditions on the peptoid microsphere coatings, including (i) helicity, (ii) temperature, (iii) pH, and (iv) ionic strength, show thatMicrosphere size decreases with increasing peptoid helicity and the positively charged side chains are positioned on the outside of the microspheres.
Journal ArticleDOI
Study on eruption of heat for Escherichia coli B aroused by lanthanum nitrate and its mechanism
TL;DR: The results show that the growth and multiplication of cells were inhibited and that the biomass decreased at high concentration of lanthanum nitrate, and this phenomenon was named as “eruption of heat”.
Journal ArticleDOI
CFD analysis of a TG–DSC apparatus: Application to the indium heating and phase change process
TL;DR: In this article, a CAD model of the real device was built and meshed in detail, in order to take into account the small scale processes which occur inside the crucibles, and several theoretical models, some previously existing in the CFD software used and others developed ad hoc, were applied to simulate the whole facility.
Journal ArticleDOI
Comparative physical–chemical characterization of encapsulated lipid-based isotretinoin products assessed by particle size distribution and thermal behavior analyses
Carla Aiolfi Guimarães,Farid Menaa,Bouzid Menaa,Joyce Santos Quenca-Guillen,Jivaldo do Rosário Matos,Lucildes Pita Mercuri,André Borges Braz,Fábia Cristina Rossetti,Erika Rosa Maria Kedor-Hackmann,Maria Inês Rocha Miritello Santoro +9 more
TL;DR: It is shown that the PSD, estimated by laser diffraction and by polarized light microscopy, differed between the generics and the reference product, and that PSD analyses in isotretinoin lipid-based formulations should be routinely performed in order to improve their quality and bioavailability.
References
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Book
Enantiomers, Racemates, and Resolutions
TL;DR: RACEMATE and their ENANTIOMER CONSTITUENTS Types of Crystalline Racemates Binary Mixtures of Enantiomers Solution Properties as mentioned in this paper.
Journal ArticleDOI
Characteristics and Significance of the Amorphous State in Pharmaceutical Systems
Bruno C. Hancock,George Zografi +1 more
TL;DR: The amorphous state is critical in determining the solid-state physical and chemical properties of many pharmaceutical dosage forms and some of the most common methods that can be used to measure them are described.
Journal ArticleDOI
Solid dispersion of poorly water‐soluble drugs: Early promises, subsequent problems, and recent breakthroughs
TL;DR: Commercial use of solid dispersion systems during the past four decades has been very limited, primarily because of manufacturing difficulties and stability problems, but this has been changing in recent years because of the availability of surface-active and self-emulsifying carriers and the development of technologies to encapsulate solid dispersions directly into hard gelatin capsules as melts.
Book
Polymorphism in Pharmaceutical Solids
TL;DR: Brittain et al. as mentioned in this paper applied the phase rule to the characterisation of polymorphic and solvatomorphic systems, and proposed a computational method to predict polymorphism.
Book ChapterDOI
Crystalline Polymorphism of Organic Compounds
TL;DR: A wide variety of techniques appropriate to the study of organic crystalline polymorphism and pseu-dopolymorphism is then surveyed, ranging from simple crystal density measurement to observation of polymorphic transformations using variable-temperature synchrotron X-ray diffraction methods.