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Studies on dissolution testing of the nifedipine gastrointestinal therapeutic system. II. Improved in vitro-in vivo correlation using a two-phase dissolution test Studies on dissolution testing of the nifedipine gastrointestinal therapeutic system. II. Improved in vitro-in vivo correlation using a two-phase dissolution test

The nifedipine gastrointestinal therapeutic system (GITS) produces relatively linear fractional absorption-time plots between 6 and 24 h and about 70% of the available dose is absorbed within 24 h in human beings. However, conventional single-phase in vitro dissolution tests with the GITS demonstrate pseudo zero-order release of nifedipine suspension between about 2 to 20 h and ≥90% of the labeled dose is released within 24

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Biorelevant test for supersaturable formulation Biorelevant test for supersaturable formulation

Supersaturable formulation can generate supersaturation after dissolution, providing kinetic advantage in vivo. However, the supersaturation may precipitate before being absorbed, which makes it difficult to ensure and predict its in vivo performance. The traditional USP method is typically for Quality Control (QC) purpose and cannot be used to predict the formulation in vivo performance. Therefore, there is generally a lack of a predictive biorelevant testing method. In this review, different types of supersaturable formulations are described, including amorphous dispersions, polymorphs, salts/co-crystals, weak base and supersaturable solubilized formulations

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A comparison of the in vitro permeation of niacinamide in mammalian skin and in the Parallel Artificial Membrane Permeation Assay (PAMPA) model A comparison of the in vitro permeation of niacinamide in mammalian skin and in the Parallel Artificial Membrane Permeation Assay (PAMPA) model Login
Glatiramer acetate persists at the injection site and draining lymph nodes via electrostatically-induced aggregation Glatiramer acetate persists at the injection site and draining lymph nodes via electrostatically-induced aggregation Login
Improving the outcomes of biopharmaceutical delivery via the subcutaneous route by understanding the chemical, physical and physiological properties of the subcutaneous injection site Improving the outcomes of biopharmaceutical delivery via the subcutaneous route by understanding the chemical, physical and physiological properties of the subcutaneous injection site

Subcutaneous (SC) injection is currently the most common route of self-administering biopharmaceuticals such as proteins and peptides. While pharmaceutical scientists have acquired great skill in identifying formulations for these proteins and peptides with multi-year shelf life stability, the SC injection of these formulations can result in inconsistent or particularly low bioavailability outcomes. We hypothesise that upon injection, the chemical, physical and physiological properties of the subcutaneous tissue may play a crucial role in determining the therapeutic outcomes of SC injected biopharmaceuticals

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A novel in vitro method to model the fate of subcutaneously administered biopharmaceuticals and associated formulation components A novel in vitro method to model the fate of subcutaneously administered biopharmaceuticals and associated formulation components

Subcutaneous (SC) injection is becoming a more common route for the administration of biopharmaceuticals. Currently, there is no reliable in vitro method that can be used to anticipate the in vivo performance of a biopharmaceutical formulation intended for SC injection. Nor is there an animal model that can predict in vivo outcomes such as bioavailability in humans. We address this unmet need by the development of a novel in vitro system, termed Scissor (Subcutaneous Injection Site Simulator)

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Mechanistic Study of Belinostat Oral Absorption From Spray-Dried Dispersions Mechanistic Study of Belinostat Oral Absorption From Spray-Dried Dispersions

Spray-dried dispersions (SDDs) are an important technology for enhancing the oral bioavailability of poorly water-soluble drugs. . This work combined in vivo and in vitro tests with in silico modeling to identify the rate-determining steps for oral absorption of belinostat SDDs made with 3 different polymers (PVP K30, PVP VA64, and HPMCAS-M)

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UV imaging in pharmaceutical analysis UV imaging in pharmaceutical analysis

UV imaging provides spatially and temporally resolved absorbance measurements, which are highly useful in pharmaceutical analysis. Commercial UV imaging instrumentation was originally developed as a detector for separation sciences, but the main use is in the area of in vitro dissolution and release testing studies. The review covers the basic principles of the technology and summarizes the main applications in relation to intrinsic dissolution rate determination, excipient compatibility studies and in vitro release characterization of drug substances and vehicles intended for parenteral administratio

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Dissolution enhancement of griseofulvin from griseofulvin-sodium dodecyl sulfate discs investigated by UV imaging Dissolution enhancement of griseofulvin from griseofulvin-sodium dodecyl sulfate discs investigated by UV imaging

The purpose of study was to investigate the dissolution rate enhancement obtained when sodium dodecyl sulfate (SDS) is co-compressed with griseofulvin into discs using a UV imaging-based flow-through dissolution testing setup

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Application of UV Imaging in Formulation Development Application of UV Imaging in Formulation Development Login
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