A Survey on Qualities of Drugs Commercially Avilable in Thailand

 In our programme on quality evaluation of generic drug products, over ten items of those commercially produced by local manufacturers were investigated for their in vitro qualities as compared to those of innovator’s using pharmacopeial methods.  On the basis of pharmacopeial specification, substandard qualities were found in 14 items out of 17.  For each generic drug, there is a great variation in qualities among different manufacturers.  All tested samples of all products pass the pharmacopeial standard with regard to weight variation and content uniformity.  Failure to meet the percent labelled amount limit was observed for spironolactone and ranitidine tablets.  An achievement in disintegration test was generally shown, though in the recent pharmacopeia, no requirement on disintegration was specified.  Failure to pass the dissolution specification was demonstrated in tablets of paracetamol, cimetidine, ranitidine, ibuprofen, spironolactone, naproxensodium, danazol, hydroxyzine, terfenadine, ketotifen, metronidazole, alprazolam, cotrimoxazole and ampicillin.  For drugs locally manufactured, their qualities on the basis of pharmacopeial requirement, still need improvement, particularly to enhance the dissolution property.

Comparison of in in vitro Evaluation of Commercially Available Trimethoprim-Sulphamethoxazole Tablets.

 Five commercial brands of combined formulations of 1:5 Trimethoprim and Sulphamethoxazole were evaluated, in vitro, for their weight variation, the percent labelled amount of active ingredients, hardness, disintegration time and dissolution rate by the official pharmacopoeal methods.  All brands meet the pharmacopoeal requirements with regard to content uniformity; disintegration time and the percentage of Sulphamethoxazole whereas Trimethoprim content was not within the USP range in some commercial formulations.  Variation among different brands was demonstrated by diverse dissolution rates and profiles.  Only brand A and B passed the USP dissolution test and no statistically-significant difference was noted for both Trimethoprim and Sulphamethoxazole.  Based on the previous correlation study between in vitro dissolution and in vivo absorption rate of Trimethoprim, it was recommended that dissolution data could predict the bioavailability of this drug.  It is concluded that only brand A and B passed all major essential requirements of the official compendium and accordingly improvement with respect to dissolution characteristic for others is needed.

Hypothetical Models Of Dopamine D-1 Receptor

A number of dopamine receptor models have been proposed based on diverse chemical classes of compounds and different pharmacological systems.  The McDermed receptor model, the most well accepted one, which may be considered as a prototype of current models of both D-1and D-2 receptor provided the suggestion of two essential binding sites and a zone of steric occlusion. In this study, a series of beta-phenyldopamine and its conformationally restricted dopamine analogs are compared, on the basis of conformation rigidity and planarity of the molecule, with the pharmacological evaluation for D-1 and DA-1 activities.  The structural activity relationship data provides the suggestion that there may be an accessory site for D-1 receptor subtype.  This site may be considered as hydrophobic region which is believed to be complimentary with phenyl moiety of 1-phenyl-3-ben-zazepine analogs or the unsubstituted phenyl ring of dihydroxynomifensine derivatives as well as beta-phenyldopamine analogs.

Clinical Efficacy of Plai Gel Containing 1% Plai Oil in the Treatment of Mild to Moderate Acne Vulgaris

The objective of this study is to test the efficacy and safety of Plai gel containing 1% Plai oil in treatment of mild to moderate acne vulgaris. Randomized, double blinded, placebo controlled trial was conducted in 60 healthy volunteers. The primary outcome is expressed in percentage reduction in total acne lesions (inflammatory lesions and non inflammatory lesions). Assessments were performed at week 2, 4, and 8. A percentage reduction in total acne lesions in plai group was higher than the placebo group at week 2 [6 times (95%CI: -16 to 28)] and week 4 [12 times (95%CI: -12 to 35)]. A percentage reduction in noninflammatory acne lesions in plai group was higher than the placebo group at week 2 [14 times (95%CI: -17 to 43)] and week 4 [26 times (95%CI: -4 to 64)]. However, such differences did not show statistical significance. At week 8, there were no differences between two groups. The plai group showed a significant reduction of noninflammatory acne lesions from the baseline at week 2 (45 ± 29 lesions) and week 4 (41 ± 25 lesions), while the placebo did not so. A percentage reduction in inflammatory acne lesions in plai group was lower than the placebo group at week 2 [2.9 (95%CI:-37.6 to 31.8)] and week 4 [12.1 (95%CI:-42.2 to 17.9), however, there were no significant differences. For the secondary outcome, success rate at week 8 was 39% in plai group and 31% in placebo group. However, this difference did not show statistical significance. Plai gel was safe. Adverse events were not found in this study. The compliance to use plai gel was greater than 90%. In conclusion, plai gel is promising to be used in treatment of mild to moderate acne, which the effect could be seen within the first month as compared to placebo.

Economic Evaluation of Disease Management Program : A Cases Study of Open Heart Surgery

This study aimed to analyze the cost effectiveness for open heart surgery in disease management program compared with usual care. This study analyzed the cost effectiveness for coronary bypass grafting (CABG) in the 60 years old patients and open heart surgery for patients with valvular heart disease in 40 years old patients. Decision Analysis Model was used to calculate life expectancy, quality-adjusted life expectancy (QALY), lifetime cost and incremental cost-effectiveness ration (ICER). The disease management program was assumed to increase the proportion of patients receiving the surgery by 30% and reduce the proportion of patients who received delayed surgery by 40% when compared with usual care. Mortality rate in the first year of the surgery was based on the clinical data of Queen Sirikit Heart Center of the Northeast, Khon Kaen University. Mortality rate in the second year after surgery and thereafter was obtained from published literatures. Cost data were abstracted from electronic databases of Maharat Nakhonratchasima Hospital and obtained from DGR system. Quality of life data were based on the study of quality of life outcome measured by EuroQol VAS among patients with open heart surgery under the disease management program. Time horizons were 20 years for CABG and 40 years for VHD surgery. Compared to usual care, CABG under the disease management program improved life expectancy and QALY, and was more costly. Life expectancy were 9.83 and 9.36 years which were equivalent to 6.29 and 5.82 QALYs for disease management program and usual care, respectively. An ICER of the disease management program as compared with usual care was 17,276 Baht per QALY. For surgery in VHD, compared with usual care, the disease management program also improved life expectancy and QALY, and was more costly. Life expectancy were 13.17 and 11.54 years which were equivalent to 11.54 and 7.35 QALYs for the disease management program and usual care, respectively. An ICER of the disease management program as compared with usual care was 5,904 Baht per QALY. A cost effectiveness acceptability curve, based on Monte Carlo simulation suggests that at a willingness to pay (WTP) threshold of more than 15,000 Baht per QALY, more than 50% of CABG in the disease management program will be cost effective. For the surgery for VHD, at a WTP threshold of more than 10,000 Baht per QALY, more than 50% of surgery for VHD under the disease management program will be cost effective. Based on the WHO cost-effectiveness threshold, open heart surgery under the disease management program is considered the cost-effectiveness management when compared to usual care.

Quality Indicators for Diabetes Care in Practice Guidelines and Applying in the District Hospital

This study had two main objectives. The first objective was to conduct a systematic document review to identify and summarize quality indicators of diabetes care. An electronic search of English and Thai language literature published between 1990 and 2008 was performed. Eleven established guidelines were included. Thirty-eight indicators were extracted and categorized into eight diabetes management topics: glycemic control, nephropathy assessment, lipid profile assessment, eye examination, foot examination, blood pressure control, antiplatelet use, and others. The secondary objective was to perform a cross-sectional study to describe the quality of diabetes care in term of process and outcome in two district hospitals in Amnatcharoen Province. All diabetic patients who had fasting blood sugar (FBS) monitored at least three times per year during the period 2003 to 2007, were analyzed by hospital electronic database and medical chart review. In 2003, 2004, 2005, 2006, and 2007, there were 759, 991, 1,212, 1,389, and 1,481 diabetic patients, respectively. The proportions of serum creatinine and lipid profile monitoring increased gradually over time whereas HbA1c and proteinuria monitoring was performed in a small number of cases. The hospitals began to provide complete foot examinations in 2007 and nearly half of patients were examined. The percentage of the patients receiving eye examinations varied over the years. The proportion of patients who were prescribed angiotensin-converting enzyme inhibitors improved substantially between 2003 (17%) and 2007 (49%), whereas most patients were not prescribed aspirin and statins during these years. The percentage of the patients who reached the American Diabetes Association (ADA) 2004 goals of therapy for FBS and blood pressure were relatively low over the five year period. In conclusion, most processes of diabetes care were improved over the five year period. However, there is still room for improvement in the quality of diabetes care in district hospitals. Appropriate management programs should be implemented to improve diabetes care.