Nanoemulgel for Improved Topical Delivery of Desonide: Formulation Design and Characterization.

This research aimed to develop a novel drug delivery system to improve treatment of skin disorders. The system is comprised of a Carbopol 980-based nanoemulgel (NE-gel) containing a desonide (DES; 0.05%, w/w) nanoemulsion (NE), which has a small particle size, high encapsulation efficiency, good thermodynamic stability, good permeation ability, and high skin retention. DES-loaded NE (DES-NE) was prepared by high-pressure homogenization. The developed formulation was characterized by differential scanning calorimetry (DSC), X-ray diffraction, drug release, skin permeation, and drug retention. DES in vitro release and skin permeation studies with different formulations of artificial membrane and rat abdominal skin were performed with the Franz diffusion cell system. Confocal laser scanning microscopy (CLSM) was used to detect the localization and permeation pathways of drugs in the skin. Compared with commercially available gel (CA-gel) and NE, the NE-gel release process conformed to the Higuchi release model (R2 = 0.9813). NE-gel prolonged the drug release time and allowed for reduced administration dose and frequency. The unit cumulative permeation of NE and NE-gel through the skin for 12 h was 63.13 ± 2.78 and 42.53 ± 2.06 µg/cm2, respectively, values significantly higher (p < 0.01) than that of the CA-gel (30.65 ± 1.25 µg/cm2) and CA-cream (15.21 ± 0.97 µg/cm2). The DES-NE and DES NE-gel skin drug retention was significantly higher than commercially available formulations (p < 0.01). Hence, the prepared NE-gel is a potential vehicle for improved topical DES delivery for better treatment of skin disorders.

Preparation and characterization of bupivacaine multivesicular liposome: A QbD study about the effects of formulation and process on critical quality attributes.

This study extends QbD principles to liposomal products containing a hydrophilic active pharmaceutical ingredient (API). The feasibility and advantages of the QbD concept for multivesicular liposome-based systems were demonstrated. We selected the local anesthetic drug bupivacaine as a model compound. Desired properties for three critical attributes of multivesicular liposome drug products, namely, the particle size, morphology, and drug encapsulation efficiency, were defined and evaluated. The liposome preparation process significantly affected both the liposome particle size and drug encapsulation efficiency. In this study, the effects of material attributes and processing parameters during the preparation of liposomes were studied in detail using a microscope and particle size analyzer. We used risk assessment to monitor several factors that substantially affect the encapsulation rate and particle size.

Evaluation of exhalation valves.

Certification tests currently employed by some industrialized nations to certify respirators require that when challenged with air flow at a constant suction head of 25 mmH2O, the leakage into the facepiece from the exhalation valve(s) should not exceed 30 ml min(-1). However, the test alone might not reflect the leakage rate under different levels of vacuum. To study the characteristics of leakage through exhalation valves, a leakage meter was built to measure the leakage rate of four brands of exhalation valves. Seven valves of each brand were tested for leakage rate at pressure drops ranging from 15 to 45 mmH2O (or extended to 75 mmH2O for some valves). Two types of leaks, i.e. fiber insertion and arch dent on the valve seat, were used to investigate the effect of leak shape on the characteristic leak flow as a function of pressure drop. A leakage data point represented a mean value of five measurements. The results showed that the leakage rate could increase or decrease with increasing pressure drop inside the respirators, indicating that the current method of conducting leakage tests, at a constant suction head of 25 mmH2O, does not guarantee better protection than when the respirators are used at a lower suction head. Moreover, based on the sample valves tested in this study, it was found that valve leakage was mostly caused by defects in the valve seats. Both fiber-insertion and arch-dent leaks had either increasing or decreasing characteristic curves, depending on the size of the leak and the material of the valve membrane.