Over 3 years, the number of pharmaceutical drugs suspended from distribution system by the Drug Administration of Vietnam is 142 drugs in 1997, 103 drugs in 1998, and 11 pharmaceuticals in 1999. Analyzing the list of these pharmaceuticals reveals that:* About 70% drugs suspended from existing distribution system have a long remained time in expiry date, meaning that these products could not meet technical specifications after manufacturing date. More than 75% suspended pharmaceuticals do not meet quality standards, especially those related to quantitative assay. Therefore, the instability of quality remains the major reason for pharmaceutical drug suspension. *Vitamin and traditional drugs are of the two pharmaceutical groups, which have low stability of quality. In 1999, most of drugs contained Vitamin B12 were under rank of the technical specification. Traditional medicines were suspended for not reaching standards on microbiology, on taking a look of outward appearance, and for containing chemicals that do not register in the formulation. There should have some recommendations for manufactures and managers to improve quality of pharmaceuticals distributed in the market
Pharmaceutical Preparations ; Drug Stability

Flowers of Sophora japonica were processed at nature conditions in Ho Chi Minh City after followed the stability within 2 years by rutin quantitative method follow Vietnamese pharmacopoeia III- 2002 by spectrophotometer and quantify quercetin by High-Perfomance Liquid Chromatography (HPLC). Results: the content of rutin in flowers of Sophora japonica decreased across preservation time (from 6 to 11%) and quercetin mixture did not increase significantly (approximate 0.1%). The rutin content of flowers of Sophora japonica was still high compared to Vietnamese pharmacopoeia III- 2002 standards. Thus, the shelf-life of the flowers of Sophora japonica is proposed to be 30 months if well preserved
Flowers ; Drug Stability

The research was done to monitor the stability of quality, which are currently distributed in the market. The sample size is of 136 drugs with expiry date, which are selected from retail pharmacies in Hanoi. These 136 drugs represent both domestic-made and imported products, different kinds of pharmaceutics and various groups of pharmacology. Results show that 11.0% of 136 studied pharmaceuticals do not meet the technical specifications. Among this, 7.4% fail to meet standards on quantitative assay. The rate of domestic made pharmaceuticals under its quantitative assay is twice higher than imported ones. Vitamin and traditional products are of the two drug groups having low stability. Almost drugs currently sold in the market have long expiry. However, there remains a considerable ratio of pharmaceuticals drugs under the quality standards.
Pharmaceutical Preparations ; Drug Stability ; Marketing

Study on some influencing factors such as buffer, antioxidant substances to build primary formulation of tobramycin eye drops with stability over 12 months. Result: temperature and light have much influence to the stability of tobramycin and pH contents of eye drops solution. High temperature impacts clearly to the decrease of tobramycin pH and contents. The solution was stable with borate buffer more than phosphate and citrate buffer. Product samples without antioxidant substances have low remained tobramycin contents, about 70% after three months ageing. Dinatri EDTA, natri bisulfit and dinatri EDTA-natri bisulfit combination have significant effect to the stable of tobramycin content. However, dinatri EDTA choice compared with dinatri EDTA-natri bisulfit combination is the same because of dinatri EDTA effect. Dinatri EDTA has better effect to the stable of pH and increase anti-bacteria effect of benzalkonium chloride
Ophthalmic Solutions ; Tobramycin ; Drug Stability

Study on white sewer- rat. Result: stable degree of injection solution Ned 2,5% depend on propylen glycol rate in sloven mixture used to compound drug, pH of solution, type of antioxygen agent, antioxygen agent level, agent of cooperate against oxygen and high of propylen glycol and pH in injection solution level.
Sodium ; pharmacokinetics ; Drug Stability ; drugs ;

Glutathione is an important component of the UW cold storage solution, but it is oxidized during storage. The experimental study has been carried out to determine the effect of air oxygen on stability of glutathione solution. The results of this study demonstrated that the main cause of decreasing concentration of sulfhydril glutathione is the air oxygen on surface of and within solution
Glutathione ; Oxygen ; Drug Stability ; drugs

OBJECTIVETo study the total content change of psoralea and isopsoralea in Psoralea corylifolia under different temperature, and predict its term of validity by initial average rate stability test in order to provide the basis for assessing its quality.

METHODThe reaction rate constant K was replaced by initial velocity V. According to Arrhenius rule, storage period was obtained at room temperature.

RESULTThe stable life of P. corylifolia has been determined as 0.53 years.

CONCLUSIONThe high temperature is not conducive to the stability of the P. corylifolia, which need to store in a dark and cool place.

OBJECTIVETo prepare Form A and Form B of benazepril hydrochloride and to compare the differences in spectrums, thermodynamics and crystal structure between two polymorphic forms.

METHODSForm A and Form B of benazepril hydrochloride were characterized by Fourier transform infrared spectroscopy (IR), thermal gravimetric analysis (TG), differential scanning calorimetry (DSC), powder x-ray diffraction (PXRD) and single crystal x-ray diffraction (SCXRD).

RESULTSPreparation method, crystal structure and polymorphic stability of Form A and Form B of benazepril hydrochloride were obtained. Based on the analysis of crystal structure of both polymorphs, Form A belonged to monoclone space group P2(1) with a=7.8655(4)Å, b= 11.7700(6)Å, c= 13.5560(7)Å, β= 102.9470(10)°, V=1223.07 (11)Å(3) and Z=2, while Form B belonged to orthorhombic space group P212121, with a=7.9353(8)Å, b=11.6654(11)Å, c=26.6453(16)Å, V=2466.5(4)Å(3) and Z=4. From the DSC and XRD results, Form B of benazepril hydrochloride could be transformed into Form A after heating treatment.

CONCLUSIONForm A and Form B of benazepril hydrochloride are both anhydrous and displayed different polymorphs due to different molecular configuration. Furthermore, Form A exhibits more stable than Form B at high temperatures.

AIMTo simplify the study on the effect of relative humidity and temperature on drug stability.

METHODSThe stability of penicillin potassium as a model was studied with programmed humidifying and heating.

RESULTSResults of our programmed humidifying and heating experiments are comparable to those of traditional experiment at constant humidity and temperature.

CONCLUSIONProgrammed humidifying and heating experiments are applicable to drug stability study.

Drug Stability ; Methylprednisolone Hemisuccinate ; administration & dosage