Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test.

The sterility test described in pharmacopoeial compendia requires a 14-day incubation period to obtain a valid analytical result. Therefore, the use of alternative methods to evaluate the sterility of pharmaceuticals, such as the BacT/Alert® 3D system, is particularly interesting, because it allows a reduced incubation period and lower associated costs. Considering that the BacT/Alert® 3D system offers several culture media formulations developed for this microbial detection system, the present study was aimed to evaluate and compare the performance of BacT/Alert® 3D with the pharmacopoeial sterility test.

Drug-eluting silicone hydrogel for therapeutic contact lenses: Impact of sterilization methods on the system performance.

Although contact lenses are promising platforms for ocular drug delivery and have been extensively studied for that purpose, the influence of sterilization methods on these systems remains barely investigated. In this work, a silicone-based hydrogel was produced and loaded with different ophthalmic drugs: levofloxacin, chlorhexidine, diclofenac and timolol. The drug release profiles, along with several material properties, were evaluated before and after sterilization by three different methods steam heat, γ-irradiation and ozone gas.

Sterilization of silicone-based hydrogels for biomedical application using ozone gas: Comparison with conventional techniques.

Sterilization of hydrogels is challenging due to their often reported sensitivity to conventional methods involving heat or radiation. Although aseptic manufacturing is a possibility, terminal sterilization is safer in biological terms, leading to a higher overall efficiency, and thus should be used whenever it is possible. The main goal of this work was to study the applicability of an innovative ozone gas terminal sterilization method for silicone-based hydrogels and compare its efficacy and effects with those of traditional sterilization methods: steam heat and gamma irradiation.

Hydrogel Based Drug Delivery Systems: A Review with Special Emphasis on Challenges Associated with Decontamination of Hydrogels and Biomaterials.

Background: Many researches involving the development of new techniques and biomaterials to formulate a suitable drug delivery system and tissue engineering have been conducted. The majority of published literature from these researches emphasizes the production and materials characterization. The safety aspect of hydrogels and biomaterials is a major constraint in their biological applications.

Preparation and characterization of metoprolol tartrate containing matrix type transdermal drug delivery system.

The present study aimed to develop matrix-type transdermal drug delivery system (TDDS) of metoprolol tartrate using polyvinyl pyrrolidone (PVP) and polyvinyl alcohol (PVA). The transdermal films were evaluated for physical parameters, Fourier transform infrared spectroscopy analysis (FTIR), differential scanning calorimetry (DSC), in vitro drug release, in vitro skin permeability, skin irritation test and stability studies. The films were found to be tough, non-sticky, easily moldable and possess good tensile strength.

The Microbial Quality Aspects and Decontamination Approaches for the Herbal Medicinal Plants and Products: An in-Depth Review.

Background: The present review article provides an overview of the published literature concerning microbial quality of medicinal plants and products and their decontamination methods. It is important to analyze different aspects regarding the cultivation, growing, harvesting, storage, manufacturing, and decontamination of medicinal plant products. Herbal medicinal plants bear a massive microbial load leading to contamination and mycotoxin, which needs to be considered, and properly controlled using suitable sterilization and decontamination methods.

New microbiological assay for determination of caspofungin in the presence of its degradation products and its measurement uncertainty.

Caspofungin is an echinocandin antifungal used in the treatment of invasive fungal infections. Several methods have been reported for the quantitative analysis of echinocandins; however, there is no microbiological assay for determination of caspofungin potency in the presence of its degradation products. This study aimed to develop and validate a microbiological method for quantitative analysis of caspofungin in lyophilized powder, evaluate the stability, and determinate the degradation kinetics of the drug when the finished product is submitted to heat stress.

Development and validation of liquid chromatographic and ultraviolet derivative spectrophotometric methods for determination of epinastine hydrochloride in coated tablets.

High-performance liquid chromatographic (LC) and ultraviolet derivative spectrophotometric (UVD) methods were developed and validated for the quantitative determination of epinastine hydrochloride in coated tablets. LC was performed on a reversed-phase RP-18 column with a mobile phase composed of 0.3% triethylamine (pH adjusted to 4.