CT-based vertebral three-dimensional Hounsfield unit can predict the new vertebral fracture after percutaneous vertebral augmentation in postmenopausal women: a retrospective study.

Background: Vertebral Hounsfield unit (HU) were regarded as a new way to predict fragility fracture. However, HU values were measured in a single plane, which is not accurate for the entire vertebral body. This study aimed to create a new CT-based metric for assessing bone mineral density, three-dimensional Hounsfield unit value (3D-HU), and to evaluate its effect in independently predicting new vertebral fracture (NVF) after percutaneous vertebral augmentation (PVA) in postmenopausal women.

Biopharmaceutical Evaluation and CMC Aspects of Oral Modified Release Formulations.

This article discusses the range of outcomes from biopharmaceutical studies of specific modified release (MR) product examples in preclinical models and humans. It touches upon five major biopharmaceutical areas for MR drug products: (1) evidence for regional permeability throughout the GI tract, (2) susceptibility to food-effect, (3) susceptibility to pH-effect, (4) impact of chronopharmacology in designing MR products, and (5) implications to narrow therapeutic index products. Robust bioperformance requires that product quality is met through a thorough understanding of the appropriate critical quality attributes that ensure reliable and robust manufacture of a MR dosage form.

Pharmaceutical development and regulatory considerations for nanoparticles and nanoparticulate drug delivery systems.

Pharmaceutical nanomaterials (NMs) encompass a wide variety of materials including drug nanoparticles (NPs), which can be amorphous or crystalline; or nanoparticulate drug delivery systems, such as micelles, microemulsions, liposomes, drug-polymer conjugates, and antibody-drug conjugates. These NMs are either transient or persistent-depending on whether the integrity of their structure and size is maintained until reaching the site of drug action. Examples of several approved drug products are included as pharmaceutical nanoparticulate systems along with a commentary on the current development issues and paradigms for various categories of NPs.

Generic development of topical dermatologic products, Part II: quality by design for topical semisolid products.

The emergence of quality by design as a relatively new systematic science and risk-based approach has added a new dimension to pharmaceutical development and manufacturing. This review attempts to discuss the quality by design elements and concepts applied for topical semisolid products. Quality by design begins with defining a quality target product profile as well as critical quality attributes.

Generic development of topical dermatologic products: formulation development, process development, and testing of topical dermatologic products.

This review presents considerations which can be employed during the development of a semi-solid topical generic product. This includes a discussion on the implementation of quality by design concepts during development to ensure the generic drug product has similar desired quality attributes to the reference-listed drug (RLD) and ensure batch to batch consistency through commercial production. This encompasses the concept of reverse-engineering to copy the RLD as a strategy during product development to ensure qualitative (Q1) and quantitative (Q2) formulation similarity, as well as similarity in formulation microstructure (Q3).

Ion-exchange resins as drug delivery carriers.

There are many reports in the literature referring to the utilization of drug bound to ion-exchange resin (drug-resinate), especially in the drug delivery area. Ion-exchange resin complexes, which can be prepared from both acidic and basic drugs, have been widely studied and marketed. Salts of cationic and anionic exchange resins are insoluble complexes in which drug release results from exchange of bound drug ions by ions normally present in body fluids.

Effect of a lipoidic excipient on the absorption profile of compound UK 81252 in dogs after oral administration.

Purpose: Effect of caprylocaproyl macrogolglycerides (Labrasol), as a lipoidic excipient/vehicle in an oral capsule formulation, on pharmacokinetic disposition of a BCS Class 3 compound, UK-81252, was investigated in vivo in a canine model.

Methods: The control and lipoidic formulations were administrated to six Beagle dogs in a crossover, single dose design with a 2-week washout period in between treatments. The plasma concentration-time profile for the lipoidic formulation was compared to that of the control formulation (lactose-based oral capsule).

Effect of hydroxypropyl beta-cyclodextrin on drug solubility in water-propylene glycol mixtures.

Combined effects of cosolvency and inclusion complexation on drug solubility were studied using a model hydrophobic compound (carbamazepine) and a model hydrophilic compound (Compound S). Propylene glycol (PG) was used as the nonaqueous solvent, and deionized water was employed for the aqueous systems. Hydroxypropyl beta-cyclodextrin (HPbetaCD) was chosen as the complexing agent and studied at concentrations up to 28% (w/v).

Evaluation of the in vivo disintegration of solid dosage forms of a bile acid sequestrant in dogs using gamma-scintigraphy and correlation to in vitro disintegration.

Purpose: [corrected] To evaluate the in vivo disintegration behavior of tablets and capsules of a bile acid sequestrant, DMP 504, in beagle dogs and to assess the significance of the in vitro disintegration of the dosage forms on subsequent in vivo behavior in order to draw possible in vitro-in vivo correlations.

Methods: Tablet and capsule formulations of a bile acid sequestrant, DMP 504, were formulated with samarium oxide and neutron activated to produce radioactive 53Sm to noninvasively evaluate their in vivo behavior in beagle dogs by gamma-scintigraphy. A four-way crossover design was completed (n = 4) in which (a) tablets from two different batches were administered under the fasted condition and manufactured using different lots of drug substance where one batch exhibited relatively faster in vitro disintegration time (30 min) than the other tablet batch, which resulted in slower disintegration (45 min), (b) a capsule formulation was administered to fasted beagles, and (c) the tablet having slower in vitro disintegration was also administered in the fed state, and its in vivo disintegration was compared to that observed in the fasted state.

A Comparison of Free-Flowing, Segregating and Non-Free-Flowing, Cohesive Mixing Systems in Assessing the Performance of a Modified V-Shaped Solids Mixer.

The performance of a modified V-shaped solids mixer, i.e., uneven leg or offset angle, has been reassessed by using a binary cohesive mixture, made up of 1% sodium salicylate and 99% microcry stalline cellulose, as the mixing system.