Advanced QbD-Based Process Optimization of Clopidogrel Tablets with Insights into Industrial Manufacturing Design.

: Traditional Quality by Testing (QbT) strategies rely heavily on end-product testing and offer limited insight into how critical process parameters (CPPs) influence product quality. This increases the risk of variability and inconsistent outcomes. To overcome these limitations, this study aimed to implement a Quality by Design (QbD) approach to optimize the manufacturing process of clopidogrel tablets.

Preparation of inhalable N-acetylcysteine-loaded magnetite chitosan microparticles for nitrate adsorption in particulate matter.

Airborne particulate matter has been designated as a class 1 carcinogen by the World Health Organization. Nitrate is a toxic substance that accounts for a large proportion of particulate matter, and nitrate toxicity has long been reported. In this study, we aimed to optimize the adsorption and removal of particulate matter containing nitrate for effective elimination by the lungs.

Inhaled deep eutectic solvent based-nanoemulsion of pirfenidone in idiopathic pulmonary fibrosis.

Pirfenidone (PRF), the first FDA-approved drug to treat idiopathic pulmonary fibrosis (IPF) and formulated as an oral dosage form, has many side effects. To enhance the therapeutic effect, we discovered a high-load nanoemulsion using a novel deep eutectic solvent (DES) and developed an inhalation drug with improved bioavailability. The DES of PRF and N-acetylcysteine were discovered, and their physicochemical properties were evaluated in this study.

Novel Esomeprazole Magnesium-Loaded Dual-Release Mini-Tablet Polycap: Formulation, Optimization, Characterization, and In Vivo Evaluation in Beagle Dogs.

Esomeprazole magnesium (EMP) is a proton pump inhibitor (PPI) that reduces acid secretion. EMP has a short plasma half-life (approximately 1.3 h); hence, nocturnal acid breakthrough (NAB) frequently occurs, disturbing the patient's nighttime comfort and sleep.

Novel montelukast sodium-loaded stable oral suspension bioequivalent to the commercial granules in rats.

To develop a montelukast sodium-loaded stable oral suspension bioequivalent to the commercial granules in rats, several montelukast sodium-loaded suspensions were prepared with a suspending agent, stabilizers and anti-aggregation agents, and their stabilities were investigated by visually observing the sedimentation phenomenon and determining the concentration of the degradation product. Moreover, dissolution and pharmacokinetic studies of the optimized formulation were examined in rats compared to commercial montelukast sodium-loaded granules. Avicel RC-591 (Avicel), a suspending agent, prevented the sedimentation of these suspensions at >2.

In vitro skin permeation and anti-atopic efficacy of lipid nanocarriers containing water soluble extracts of Houttuynia cordata.

Objective: The aims of this work are to enhance the in vitro skin permeation of Houttuynia cordata (water-soluble extract of H. cordata; HCWSE) and to boost the efficacy of HCWSE against atopic dermatitis (AD) - like skin lesion in hairless mice using lipid nano-carriers (liposome and cubosome).

Methods: HCWSE was obtained by a hot water extraction.

Complex coacervation-controlled release from monoolein cubic phase containing silk fibroin and alginate.

pH-dependent release from monoolein (MO) cubic phase was obtained by taking advantage of complex coacervation between hydrophobically modified alginate (HmAL) and hydrophobically modified silk fibroin (HmSF) in the water channels. The degree of coacervation was investigated at pH 3.0 by a light scattering method and the maximum coacervation was observed when the ratio of HmAL to HmSF was 1:15.

Monoolein cubic phase containing acidic proteinoid: pH-dependent release.

Objective: Monoolein (MO) cubic phase containing acidic proteinoid was prepared for a pH-dependent release.

Methods: The acidic proteinoid was prepared by a thermal-condensation reaction of Asp and Leu (9.85/0.