State-of-the-art knowledge on the regulation of advanced therapy medicinal products.

Advanced therapy medicinal products (ATMPs) constitute therapeutic agents based on obtained cells, tissues or genes representing a novel treatment opportunity in medicine. In addition, ATMPs are administered into the cells or tissues of humans from the patient's own cells, donors, or genetically modified cells. Recently, the field of developing ATMPs has become a point of attention due to the clinical efficacy expected in defeating incurable diseases such as cancers and neurodegenerative disorders. Currently, there are two modes regarding the distribution of ATMPs. First, ATMPs that might be legally authorized for marketing. Second, the patients are able to access unapproved ATMPs through the hospital exemption (HE) or clinical practice program or through the compassionate use and expanded access program. The aim of this review is to discuss state-of-the-art knowledge on the regulation of ATMPs and provide regulatory recommendations.

Polyethylene glycol on stability of chitosan microparticulate carrier for protein.

Stability enhancement of protein-loaded chitosan microparticles under storage was investigated. Chitosan glutamate at 35 kDa and bovine serum albumin as model protein drug were used in this study. The chitosan microparticles were prepared by ionotropic gelation, and polyethylene glycol 200 (PEG 200) was applied after the formation of the particles. All chitosan microparticles were kept at 25°C for 28 days. A comparison was made between those preparations with PEG 200 and without PEG 200. The changes in the physicochemical properties of the microparticles such as size, zeta potential, pH, and percent loading capacity were investigated after 0, 3, 7, 14, and 28 days of storage. It was found that the stability decreased upon storage and the aggregation of microparticles could be observed for both preparations. The reduction in the zeta potential and the increase in the pH, size, and loading capacity were observed when they were kept at a longer period. The significant change of those preparations without PEG 200 was evident after 7 days of storage whereas those with PEG 200 underwent smaller changes with enhanced stability after 28 days of storage. Therefore, this investigation gave valuable information on the stability enhancement of the microparticles. Hence, enhanced stability of chitosan glutamate microparticles for the delivery of protein could be achieved by the application of PEG 200.

Making health technology assessment information available for decision making: the development of a Thai database.

In Thailand, there is an attempt to develop the Thai HTA database in order to improve the accessibility and usefulness of HTA information. At present, the database is available online at www.db.hitap.net. The database includes (1) economic evaluation studies i.e. cost-minimization analysis, cost-effectiveness analysis, cost-benefit analysis, and cost-utility analysis, (2) outcome assessment studies i.e. randomized controlled trials, and (3) quantitative measured quality of life studies. All HTA studies related to the Thai context, and published in either Thai or English from 1990 onward, are eligible for inclusion in the database. In addition, there is a quality evaluation for each economic evaluation study which will help readers, who have limited knowledge about the method, to understand and make appropriate use of the information in their own settings. This may also raise awareness among researchers, who will conduct economic evaluation studies in the future, to adhere to the standard methodological guidelines because the quality evaluation was developed based on the national guidelines published in this supplement journal.

Effect of salts and plasticizers on stability of shellac film.

The aim of this study was to increase the stability of shellac because of the polymerization. A few approaches have been applied in this study. Shellac film was prepared in two salt forms, that is, ammonium and 2-methyl-2-amino 1-propanol salts, and a comparison was made with shellac film in free acid form. The other approach was by the application of plasticizers. These plasticizers were diethyl phathalate, triacetin, and polyethylene glycol 400 (PEG 400). Plasticized shellac and unplasticized shellac films in free acid form were then compared. All shellac films were kept in stability chamber at 40 degrees C, 75% RH for a period of 3 months. The studied parameters such as insoluble solid, acid value, mechanical properties, and water vapor permeability were detected every month. Analysis of variance (ANOVA) technique was used to analyze data. The applications of salt forms proved statistically significant (p < 0.01) to reduce the polymerization process whereas certain plasticizers could enhance the stability. PEG 400 was the only plasticizer that could show the increase in stability. The improvement of stability might be a result of the interference of a larger molecule of PEG 400 causing the difficulty in interaction among carboxyl or hydroxyl groups of shellac and the effect of lower loss of plasticizer.