Research and Testing of Water Vapor Transmission of Laminated Films for Pharmaceutical Packaging / 中国药师

Objective: To research the comparability of water vapor transmission of laminated films for pharmaceutical packaging determined by different instruments, methods and experimental conditions to provide reference and advice for the related inspection personnel.Methods: The principle, test parameters, conditions and scope of application for the testing methods for water vapor transmission in the national standard (GB) and international standards (ISO, ASTM) were compared by using three kinds of instruments based on different testing principles.Results: Different temperature and humidity conditions had great influence on the results of the same instrument.Under the same temperature and humidity, the instrument with different principles had little influence on the test results.Conclusion: Testing personnel should regularly use the standard membrane to calibrate the instrument of the sensor method.The temperature and humidity should be strictly controlled during the test.They should take measurement accuracy, personnel operation and economic loss into consideration to select the suitable method.

Propriedade de barreira à umidade de embalagens plásticas para produtos oftálmicos / Moisture barrier properties of plastic bottles for ophthalmic eye drops

As propriedades de barreira à umidade de embalagens plásticas para produtos oftálmicos de capacidade nominal de 20 mL e terminação 15 mm nos formatos cilíndrico e oval, de diferentes composições (100% Polietileno de Baixa Densidade (PEBD), 100% Polipropileno (PP) e blendas com percentuais 10% e 40% de Polietileno de Alta Densidade (PEAD) em PEBD), foram estudadas neste trabalho. Foi verificada também a influência do batoque gotejador (de maior ou menor orifício de dosagem) e a influência do fechamento na taxa de transmissão de vapor d'água. O trabalho foi conduzido sob duas condições de estocagem a 25 ºC/40% UR e a 40 ºC/75% UR. Verificou-se que o diâmetro do orifício gotejador não interferiu significativamente na perda de peso da embalagem avaliada a 25 ºC/40% UR. Sob a condição de estocagem a 40 ºC/75% UR verificou-se um aumento da taxa de transmissão de vapor d'água das embalagens comparativamente as mesmas embalagens avaliadas a 25 ºC/40% UR. O sistema de fechamento não favoreceu um acréscimo significativo da taxa de transmissão de vapor d'água, o que indica que a permeação ocorreu principalmente através do corpo da embalagem plástica. A propriedade de barreira foi influenciada pela composição da embalagem plástica chegando a uma redução média de 47% na taxa de transmissão de vapor d'água para a embalagem de PEBD com 40% PEAD em relação à embalagem com100% PEBD de formato cilíndrico. Verificou-se ainda que o formato oval, por apresentar uma maior área superficial exposta comparativamente à embalagem de formato cilíndrico, com regiões de menor espessura de parede, pode favorecer um ligeiro aumento da taxa de transmissão de vapor d'água da embalagem...

The moisture barrier properties of plastic ophthalmic product bottles of nominal capacity 20 mL and finish diameter 15 mm, in cylindrical and oval shapes, with various compositions (100% Low Density Polyethylene(LDPE), 100% polypropylene (PP) and blends with10% and 40% High Density Polyethylene (HDPE) in LDPE), were assessed in this study. The effects of the drop hole size (higher or lower dosage diameter) and the screw cap on the Water Vapor Transmission Rate (WVTR) were also assessed. This study was conducted under two conditions of storage, at 25 °C/40% RH and 40 °C/75% RH. It was observed that the drop hole diameter did not influence significantly the weight loss of the container at 25 °C/40% RH, whereas at 40°C/75% RH, the WVTR of the container was higher than that of the same package at 25 °C/40% RH.The screw cap did not significantly affect the WVTR, indicating that the permeation occurred primarily through the plastic body. The barrier property was influenced by the composition of the plastic container; thus, compared to LDPE, there was a mean reduction of 47% in the WVTR of LDPE blended with 40% HDPE, when both bottles were cylindrical. It was found that the oval shape, because of the larger exposed surface area relative to the cylindrical shape, as well as the presence of regions of thinner wall, can favor a slight increase in the WVTR of the bottle...

Comparison Study of Physical Properties between Two Silicone Gel Sheets

PURPOSE: Silicone gel sheet(SGS) is used for preventing and treating keloid or hypertrophic scars. Because the product is weak in tear strength and adherence, it requires several replacements, which requires high cost. As a solution for this problem, we developed a new silicone gel sheet, named as Scar Clinic, and confirmed its physical properties. METHODS: Tensile strength, elongation rate, adhesiveness, and water vapor transmission rate were experimentally compared between the most commonly used SGS product and the Scar Clinic. RESULTS: The newly developed SGS showed better results compared to the existed SGS in regards to tensile strength, elongation rate, adhesiveness, and water vapor transmission rate. CONCLUSION: The Scar Clinic showed higher durability and flexibility. It will be a useful product for treating scars clinically.