Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน

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Quality Indicators for Diabetes Care in Practice Guidelines and Applying in the District Hospital
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2009-12-22) Utoomporn Parinyasakulwong; Thananan Rattanachotphanit; Onanong Waleekhachonloet; Chulaporn Limwattananon; Sumon Sakolchai; Denpong Patanasethanont
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.
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(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2009-12-22) . .
Costs and Treatment Outcomes of Patients with Acute Leukemia in Sappasittiprasong Hospital, Ubonratchathani
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2009-12-22) Patcharee Kanjanawat; Dayin Koompalum; Summana Moolasarn; Anoree Surawong
The objective of this study was to determine direct medical costs and treatment outcomes of acute leukemia patients: Acute lymphoblastic leukemia (ALL), acute Myeloid leukemia (AML) and acute promyelocytic leukemia (APL), in Sappasittiprasong hospital. The study was a retrospective descriptive of newly diagnosed acute leukemia patients admitted at Sappasittiprasong hospital was carried out from October 1, 2004 to September 30, 2006. The treatment outcomes data collected for 2 years of treatment and the cost data collected for 1 year of treatment by using a health care providers perspective. As a result, 151 acute leukemia patients were enrolled; 45 were children, all received chemotherapy; 106 were adult. 2-years Survival rates of child patients with ALL, AML, and APL were 68.57%, 37.50% and 100%. In adult patients, who received chemotherapy were 6.25%, 4.69% and 25%, median survival time were 3.50, 2.87 and 14.47 months, respectively. Median survival time in adult AML patients receiving palliative chemotherapy and no chemotherapy were 0.57 and 1.03 months, respectively. The first-year of median direct medical costs for child with ALL, AML, APL were 166,544, 366,147 and 360,647 baht, and for adult patients, who received chemotherapy were 115,911, 349,658, and 169,904 baht, respectively. In conclusion, the costs and treatment outcomes of patients with acute leukemia in Sappasittiprasong hospital were varied by types of acute leukemia, treatment protocols and chemotherapy regimens. Thus, to increase patient survival rates, more studies should be conducted to determine factors associated with costs and treatment outcomes.
Enhanced Bromhexine Hydrochloride Solubility and Dissolution by Inclusion Complexation with Methylated β-cyclodextrin
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2009-12-22) Nattha Kaewnopparat; Thitima Chuchom; Arunsri Sunthornpit; Amaravadee Jangwang; Sanae Kaewnopparat
The aim of this study was to enhance the solubility and dissolution of bromhexine hydrochloride by inclusion complexation with the cyclodextrin derivative, methylated \β-cyclodextrin (M\βCD). Inclusion complexes in 1:1 molar ratio were prepared by the kneading and coevaporation methods. The solubility of drug in methylated \β-cyclodextrin was studied. The complexes were characterized by differential scanning calorimetry (DSC), X-ray diffractometry, Fourier transform infrared (FT-IR) spectroscopy and dissolution studies. The solubility of bromhexine hydrochloride increased linearly with the concentration of methylated \β-cyclodextrin. The phase-solubility profile was classified as AL-type, indicating the formation of a 1:1 stoichiometric inclusion complex with an apparent stability constant (Ks) of 110 M⁻\¹. The crystallinity of drug from inclusion complexes was reduced. The inclusion complex prepared by the coevaporation method showed interaction between drug and methylated \β-cyclodextrin. Both kneaded and coevaporated samples gave similar dissolution profiles; of 50-, and 5-fold increases in drug dissolution were observed within the first 5 mins compared to pure drug and physical mixtures, respectively. These inclusion complexes were effective in enhancing drug dissolution, with bromhexine hydrochloride completely dissolving within 10 mins.
Immunomodulating, Antioxidant and Antimicrobial Activities of Northeastern Thai Edible Plant and Medicinal Plant Extracts
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2009-12-22) Chutinun Prasitpuriprecha; Aekachai Damkliang; Payoongsak Surintha; Wasun Deelum
The aim of this study was to investigate the immunological, antioxidant and antimicrobial activities of the ethanolic extracts of four Northeastern Thai edible plants; Tiliacora triandra, Cratoxylum formosum, Kanchanaburi gratum, Polygonum odoratum and one medicinal plant; Eupatorium odoratum. The immunomodulating activity of these extracts was evaluated using mouse splenocyte proliferation by the colorimetric MTT assay. The results showed that C. formosum, K. gratum, P. odoratum and T. triandra extracts had immunostimulating activity. K. gratum and C. formosum extracts could stimulate T- and B-lymphocytes at concentration of 12.5-50 \µg/mL. P. odoratum and T. triandra extracts stimulated only T-lymphocytes at concentration of 12.5-100 \µg/mL and 12.5-25 \µg/mL, respectively, while E. odoratum extract displayed cytotoxic effect. These extracts were also examined for antioxidant activity using the DPPH assay. The ethanolic extracts of K. gratum, C. formosum and P. odoratum exhibited strong antioxidant activity with the EC₅₀ values of 8.17\±0.17, 9.9\±0.14 and 58.03\±1.02 \µg/mL, respectively. The antimicrobial activity of these extracts was investigated against the organisms Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Salmonella typhimurium, Propionibacterium acne, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger by the disc diffusion method. Results showed that all were active against S. aureus. Moreover, C. formosum, K. gratum, P. odoratum and E. odoratum extracts had some activity against B. subtilis, P. acne and P. aeruginosa. K. gratum had the most potent activity with MICs of 1.5625, 3.125, 1.5625 and 3.125 mg/mL against S. aureus, B. subtilis, P. acne and P. aeruginosa, respectively.
Individualized Therapy and Pharmacogenetic Test
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2009-12-22) Veerapol Kukongviriyapan
Variability of drug response and toxic adverse effects are primarily responsible for the failure of drug therapy. Individual variation in genetic composition in regulating pharmacokinetic and pharmacodynamic processes, such as genes of drug metabolizing enzymes and genes of receptor or enzyme of drug response is critically important in determining drug efficacy. Pharmacogenetic testing will enable selection of appropriate drugs from the beginning, avoiding the drugs that could cause serious adverse events and assortment of alternative drugs to enhance therapeutic efficacy and minimize the illness.
Comparative Study of Three Multiple Linear Regression Software Programs
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2009-12-22) Bodin Tuesuwan; Nisa Phutong; Mitr Pathipvanich
Two commercial and one free online multiple linear analysis programs were tested with simulated potentiometric titration data for accuracy in determination of equivalent point, dissociation constant and partition coefficient. In many cases, analysis of simulated data yielded inaccurate results, possibly due to programming algorithms. This study highlights a need for regression programs to be tested with simulated data to assess their limitations.
Bioaccessibility of Aflatoxin B₁ in Grinded Corn and Peanut by in vitro Digestion Model
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2009-12-22) Witchada Simla; Supatra Porasuphatana; Piyada Songsermsakul
Aflatoxin B₁ (AFB₁) is a secondary metabolite produced principally by Aspergillus flavus and Aspergillus Parasiticus. This toxin represents a significant health hazard for those exposed to it continually for a prolonged period. Aflatoxigenic molds are commonly found in corn and peanuts, and under certain conditions aflatoxins will be formed. In vitro digestion is a method that has been used to estimate the bioaccessibility of chemicals and contaminants in foods. An in vitro digestion experiment was carried out in this study to analyze the bioaccessibility of AFB₁ in grinded corn and peanut. Trifluoroacetic acid-derivatized AFB₁ was measured using a HPLC-fluorescent detector. Results indicated that the bioaccessibility of AFB₁ in grinded corn and peanut was relatively high at 95% 94%, respectively. When AFB₁-contaminated grinded corn and peanut are ingested, most of the AFB₁ will be dissolved into chyme, with this strongly influencing the bioavailability of AFB₁ in humans. This may have important implications on dietary exposure. Findings from the current study could be applied to improve risk assessment of ingested AFB₁.
Aromatherapy and Essential Oils in Thai Spa Business
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2009-12-22) Rawewan Patin; Mayuree Kanlayavattanakul; Nattaya Lourith
This study collected financial information and information on essential oils used in Thai spas via questionnaires mailed to 105 spa managers or owners who operate spas certified by the Ministry of Public Health of Thailand. The majority of investments were less than 50 million Thai Baht (64.76%), of which hotel and resort spas dominated (44.76%). The predominant spa services given were aromatherapy massage (87.20%), followed by facial and body treatment (80.78%) and steam/sauna (74.82%). Most of the spa owners used natural essential oils (77.14%) as opposed to synthetic essential oils (22.86%). The five most popular essential oils were lavender (35.71%), lemongrass (20.54%), orange (16.07%), peppermint (15.18%) and jasmine oils (12.50%), respectively. Factors affecting essential oil selection in order of importance were organoleptic properties, therapeutic efficacies, purity, certification, price, supplier and tester.
Effectiveness of Pharmaceutical Care in Type 2 Diabetes Mellitus Elderly at Kamrieng Primary Care Unit, Maha Sarakham
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2009-12-22) Paramate Tanomkit; Issara Chummalee; Usawadee Maleewong
Type 2 diabetes mellitus is a major health problem of the elderly in Thailand. The purpose of this study was to evaluate the outcomes of pharmaceutical care in elderly patients with type 2 diabetes mellitus (DM) in Kamriang primary care unit (PCU), Maha Sarakham province. A one group pretest-posttest design study was conducted to compare knowledge and health behavior, fasting blood sugar level and the numbers of drug related problems (DRPs) before and after the provision of pharmaceutical care (e.g. DM education, self-care management) by a PharmD student. The data was collected by interviewing 30 elderly volunteers, who were included by a simple random sampling technique between 5th January and 28th February, 2008. The results showed that the participants were 8 men and 22 women with mean±SD age of 67.20±5.52 and a 1-5 year history of diabetes mellitus. After receiving interventions, patients had significantly increased knowledge (p \< 0.01) and self-care management scores (p=0.02). Patients’ fasting blood glucose levels showed a significantly decrease (p \< 0.01). In terms of drug related problems, these decreased from 8 to 5 after the intervention. In conclusion, this study demonstrated the effectiveness of pharmaceutical care on the improvement of knowledge, behavior, and blood sugar level in DM patients particularly the elderly.
Development of a High Performance Liquid Chromatography with Coulometric Electrochemical Detector Method for the Analysis of Morphine in Human Plasma
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2009-12-22) Thanee Tessiri; Viroj Sumyai; Suvatana Chulavatnatol; Poj Kulvanich; Khanittha Tontisirin; Thaned Pongjanyakul; Sirikul Aumpon; Verawan Uchaipichat; Detpon Preechagoon
A HPLC method using reversed-phase chromatography coupled with a coulometric electrochemical detector (ECD) was developed for the determination of morphine in human plasma. Hydromorphone was selected as an internal standard. The compounds were extracted using solid-phase extraction with C₁₈ cartridges and separated on a reversed-phase C\¹⁸ column with the mobile phase consisting of 69% v/v phosphate buffer pH 2.2 (5 mM sodium phosphate monobasic and 0.7 mM sodium dodecyl sulfate) and 31% v/v acetonitrile. The working electrode of the ECD was set at +450 mV for analytical purposes. Under this condition, the limit of detection for morphine was 0.33 ng/mL, whereas the limit of quantitation was 1.88 ng/mL. The percent recovery, intra-day and inter-day variation of morphine determinations were in the percentage range of 85.07-93.41, 2.86-6.41 and 3.76-11.39, respectively. The frozen samples kept at -20\°C proved to be stable for at least one month prior to extraction. Also, the repeated use of cartridges for extraction was found to generate reliable results.
Adherence to Antiretroviral Therapy in HIV-Infected Adults
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2010-02-25) Kamolrat Inthisak
Acquired immunodeficiency syndrome (AIDS) is an infectious disease caused by human immunodeficiency virus (HIV). The immunity of HIV-infected patients was impaired so that they could be infected by opportunistic microorganism and lead to be fatal. Patient must comply with antiretroviral therapy (ART) and promise to adhere to the medication higher than 95% in to order achieve effective response, prevent opportunistic infection and decrease dissipated drug resistant virus to the others. The aims of this study were to assess the adherence to ART and explore the factors affecting and adherence to ARV of HIV-infected adults at SriChiangMai Hospital, Nongkai. Study was performed in 21 patients who received ART during April to June 2007. All subjects took regimen I according to National Access to Antiretroviral Programs for People Who Living with HIV and AIDs (NAPHA). Adherences to ART were assessed using visual analog scale, pill counts and medication log book. Data from visual analog scale showed that 81.6% and 61.9% of patient adhered to ART followed NAPHA criteria during 7 days and 1 month respectively, before hospital revisit. Assessment of adherence to ART by pill count and log book indicated that over 90% of patients were follow NAPHA criteria. Factors affecting on adherence were age, marriage status, occupation, communication skill of health care professional, clarify data, sufficient drug supply, numbers of drug item and ease of oral administration.
The Application of Exploratory and Confirmatory Factor Analysis for Assessing the Construct Validity of SF-36 Thai version in Chronic Renal Disease Patients
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2010-02-25) Areewan Cheawchanwattana; On-anong Waleekhachonloet; Supon Limwattananon
Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were used to assess the construct validity of SF-36 Thai version in chronic renal disease patients. The patients (n=466) were interviewed at Srinagarind Hospital during March-May 2005. Data were randomly divided into two datasets for cross-validation. The first dataset was analyzed using EFA to reveal alternative models (AMs), while the second dataset was analyzed using CFA to compare the AMs and the original model assigned by SF-36 developers (Ware model). The construct validity of SF-36 Thai version in chronic renal disease patients was confirmed in this study. Results from CFA indicated that the Ware model was more parsimony than two AMs. The constructs of two AMs that resulted from the EFA differed from that was assigned by Ware et at. The results replicated the previous study in a Taiwanese general population, and these results confirmed the suggestion of using CFA to assess the construct validity of known construct measure.
Economic Evaluation of Disease Management Program : A Cases Study of Open Heart Surgery
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2010-02-25) Pataranuch Rujirawat; Thananan Rattanachotphanit; Thitima Samkaew; Areewan Cheawchanwattana; Nutjaree Pratheepawanit Johns; Chulaporn Limwattananon; Sumon Sakolchai
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.
Therapeutic Drug Monitoring of Vancomycin at Queen Sirikit Heart Center of the Northeast
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2010-02-25) Cheardchai Soontornpas; Jintawee Chaichun; Supaporn Noimay
The purpose of this study was to investigate the therapeutic drug monitoring (TDM) of vancomycin at Queen Sirikit Heart Center of the Northeast, Thailand about the patients\’ characteristics, indicators of vancomycin, frequency of TDM service, vancomycin levels and pharmacokinetic parameters of vancomycin. The study was retrospective descriptive study in patients admitted at Queen Sirikit Heart Center of the Northeast, Thailand aged over 15 years old and received vancomycin injection during 1 June 2005 to 31 May 2007. There were 43 patients received TDM services in that time but only 27 patients were recruited in this study. The median of age, weight, serum creatinine, blood urea nitrogen and creatinine clearance were 51.00 years old, 51.20 kg, 1.40 mg/dl, 24.30 mg/dl, and 44.41 ml/min, respectively. The indications of vancomycin were for treating infection of heart, skin and heart and lung in 24, 2 and 1 patients, respectively. Fifty six of 80 TDM services could be assessed. Maximum concentrations were within and beyond therapeutic range for 19 times (33.93%) and 37 times (66.07%), respectively. Minimum concentrations were within and beyond therapeutic range for 30 times (53.57%) and 26 times (46.43%), respectively. Pharmacists had provided 39 recommendations to modify the dosage regimen of vancomycin and 34 (87.18%) recommendations had been responded by physicians as absolute following. Twenty three vancomycin level were rechecked after physician response and they became within and beyond therapeutic range for 11 and 12 times, respectively. The median of pharmacokinetic parameters; volume of distribution, elimination rate constant, half life, and vancomycin clearance were 0.7800 l/kg, 0.0545 h⁻\¹, 12.7237 h, and 35.8253 ml/min, respectively. In conclusion, the therapeutic drug monitoring of vancomycin was useful for dosage adjustment in individual patient for effectiveness of treatment outcome and to prevent adverse drug reaction.
Exploration the Results of Cancer Pain Management Following Implementation of World Health Organization (WHO) Pain Guideline
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2010-02-25) Suphat Subongkot; Sugunya Khounnikhom; Nutjaree Pratheepawanit Johns; Aunkhae Sookprasert
Background: Pain is among the most common symptoms encountered in cancer patients and remains the first priority of care.Methods: This cross sectional study aimed to explore a result of pain management at Srinagarind Hospital, Khon Kaen University following the implementation of World Health Organization (WHO) Pain Guideline. Cancer pain patients were categorized based on prior analgesic exposure into two groups; Naïve group, and Routine group. Treatments were defined according to WHO as 1) drug treatment relevant to pain severity, 2) analgesics being prescribed as around-the-clock and 3) analgesics used for break-through pain for patients receiving strong opioids.Results: From Dec 2005 to Jul 2006, 261 patients were enrolled, 93.1% (n=243) were in advanced stages and 88.5% (n=231) were in moderate to severe pain.In Naïve group (n=159), 32.7% (n=52) of patients were given analgesics following the WHO on both day 1 and day 3 of admissions; 3.8% (n=6) of patients followed WHO only on day 1; 23.3% (n=37) of patients followed WHO only on day 3 whereas 40.2% (n=64) of patients did not follow WHO on both days. A decreased pain score was greater (2.61, SD±1.5) in a group following the WHO both days on day 1 and a decreased pain score was much improved (3.9, SD±1.8) as continuing to follow WHO on day 3 (p \< 0.0001) compared to those not following WHO on both days.In Routine group (n=102), 31.4% (n=32) of patients were given analgesics following WHO guideline on both day 1 and day 3 of admission. 5.9% (n=6) of patients followed WHO only on day 1; 27.5% (n=28) of patients followed WHO only day 3 while 35.3% (n=36) of patients did not follow WHO on both days. A decreased pain score was statistically significant greater (2.6, SD±1.8) in a routine group following the WHO both days on day 1 (p \< 0.0001). Furthermore, a decreased pain score was even greater (3.9, SD±2.3) in the routine group continuing to follow WHO on day 3 compared to those not following WHO on both day 1 and day 3 of admission. The most common of adverse effects related to analgesics was constipation.Conclusions: The results demonstrated that patients who received pain management following the WHO guideline reported significantly lower pain intensity than those not following the WHO regardless the history of analgesics exposure.
Inspection Cooperation Scheme Views of Pharmaceutical Manufacturers in Thailand about the Code of Good Manufacturing Practice of the Pharmaceutical Inspection Cooperation Scheme
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2010-02-25) Somying Pumtong; Sathaporn Nimkulrat; Pannipa Akanithapichat; Kunyada Nilwas; Benjaporn Kingrungpetch; Dusadi Suriyapanpong
The aim of this survey is to investigate views of pharmaceutical manufacturers concerning the Code of Good Manufacturing Practice (GMP) of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Between 19 October and 5 December 2007, data were collected from all modern pharmaceutical manufacturers in Thailand (n=165) using mailed questionnaires. Data were analyzed using descriptive statistics and ANOVA to compare differences across the manufacturer business size as well as spearman correlation to investigate the associations among variables. Fifty-six questionnaires were completed (response rate 34%). The average age of the modern pharmaceutical manufacturers in this study was 35 years. According to business size by small and medium enterprises (SMEs), the manufacturers were divided into three groups: small, medium, and large-sized businesses (23.2%, 50.0% and 19.6% respectively). Thirty-three of the manufacturers (59%) are exporters of drug products. The respondents were asked to assess their potential to achieve the GMP of PIC/S and the data revealed that the majority rated at a moderate to high level. There was a statistically significant difference in overall potential to achieve the GMP of PIC/S scores among the three groups (p \< 0.001) and the small-sized businesses had the lowest mean scores. Regarding views of obstacles to achieve the PIC/S GMP, the comparison demonstrated a significant difference for size of manufacturer business (p=0.005). The small-sized businesses had significantly higher obstacle scores. The major obstacle faced was financial difficulties (i.e. investment in infrastructure: machines, equipments and premises). Additionally, there were correlations between sale value and overall potential; and sale value and obstacles to achieve the GMP of PIC/S (r=0.553, p \< 0.001 and r=-0.400, p=0.004 respectively). Forty-five percent of respondents suggested that Food and Drug Administration (FDA) should not enforce the GMP of PIC/S upon all modern pharmaceutical manufacturers at present as such an action could cause difficulties in management and expenditure. However, 30% agreed to comply with the GMP of PIC/S as they believed that the new GMP could increase the standards of manufacturing practice. Consequently, the image of pharmaceutical manufacturers in Thailand would be improved. The findings could be used by the FDA in order to provide a suitable option for modern pharmaceutical manufacturers and introduce a policy to explore and ultimately improve the standard of manufacturing practice in Thailand.
Method Validation of a Solid Phase Extraction, High Performance Liquid Chromatography and Electrochemical Detection Method for Determination of Azithromycin in Human Plasma
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2010-02-25) Sukanya Supattanapong; Julraht Konsil; Bung-orn Sripanidkulchai; Jeffery Roy Johns
An effective and sensitive method for the determination of azithromycin in plasma with high performance liquid chromatography (HPLC) and electrochemical detection extracted by solid phase extraction has been developed and validated. Clarithromycin was used as an internal standard. Azithromycin was extracted from 1 ml of plasma by using an Oasis® HLB (Hydrophilic-Lipophilic Balance) solid-phase extraction cartridge. After eluting with 1 ml of methanol, the sample solution was evaporated to dryness, dissolved in 100 μl phosphate buffer-methanol-acetonitrile (60:20:20, v/v/v) and 40 μl injected into the HPLC system. The lower limit of quantitation (LLOQ) was 10 ng/ml without interfering peaks. The calibration curve was linear (r² = 0.9998) over the concentration range from 10 to 400 ng/ml. The accuracy and precision were in acceptable range according to criteria of guideline for Industry: Bioanalytical Method Validation of the US FDA (2001). The mean recoveries at 30, 100 and 200 ng/ml were 85.3±5.5%, 80.1±6.8% and 82.9±2.5%, respectively. Azithromycin was stable in plasma for at least 6 h at room temperature and 6 months stored at -80°C. The post-preparative stability of spiked-samples was stable more than 24 h after preparation. The cartridge can be used two times providing deviation less than 4%. The method can be used for determination of azithromycin in plasma in pharmacokinetic study, bioavailability and bioequivalence.
Pharmacists’ Responsibilities with Respect to Dietary Supplements : Perceptions of Thai Community and Hospital Pharmacists
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2010-02-25) Tipaporn Kanjanarach; Ines Krass; Robert G. Cumming
This study aimed to explore Thai pharmacists\’ perceptions of their responsibilities when providing services in relation to dietary supplements (DS). Self-administered postal questionnaires were used to collect data from community pharmacists and hospital pharmacists in the North-eastern region of Thailand. Structural Equation Modelling was performed to develop factor models of the tasks which pharmacists perceived as their responsibilities. Data from 207 community pharmacists and 178 hospital pharmacists were used for the analysis. A factor model showed that community pharmacists perceived that their responsibilities should include five tasks: being the public\’s source of DS information; determining the necessity of DS use; advising clients in choosing DS products; giving education on eating and healthy lifestyles and providing counseling on DS use. This factor model fitted data at a moderate level (\χ\²₅=13.87, n=207, P=0.021, Relative Chi-square = 2.77, AGFI=0.92, CFI=0.96, RMSEA=0.07). The reliability of the factor model was 0.81. A factor model of hospital pharmacists showed that hospital pharmacists perceived that their responsibilities should include six tasks: being the public\’s source of DS information; determining the necessity of DS use; advising clients in choosing DS products; referring clients to doctors if using DS is not appropriate; providing counseling on DS use and reporting DS adverse effects to the authority. The factor model fitted data well (\χ\²₉=11.43, n=178, p=0.247, Relative Chi-square = 1.27, ADFI=0.95, CFI=0.99, RMSEA=0.04). The reliability of factor model was 0.84. The findings from this study suggested that although community and hospital pharmacists had different views about their responsibilities in relation to DS, both groups of pharmacists appeared to be willing to adopt professional responsibilities for safe use of DS.
Caffeine Topical Gel Formulation
(Isan Journal of Pharmaceutical Sciences - วารสารเภสัชศาสตร์อีสาน, 2010-02-25) Thanaporn Amnualkit; Suthimaln Ingkatawornwong; Duangkhae Maneenuan; Kittichote Worachotekamjorn
Caffeine was used topically as one of many ingredients in various cosmetic preparations for reducing under-eye puffiness and dark circles. Gels containing 3% w/w caffeine as an active ingredient were prepared in this study. Suitable co-solvent systems and gel-forming concentrations were studied. Their effects on caffeine release from formulation were also studied. Suitable gel formulations consisted of carbopol Ultrez-21 as a gel-forming agent and propylene glycol (PG) as a co-solvent. The result showed that the increased concentration of Carbopol Ultrez-21, affected the formulation and thereby giving higher viscosity. However, all concentrations Carbopol Ultrez-21 studied (0.2%, 0.5%, 1%, 2% and 4%) did not affect caffeine release significantly. The percentage of PG in the formulation greatly affected caffeine release. Formulation containing 15% and 30% w/w PG gave release rate from Higuchi’s equation of 2.47 ± 0.26 mg/cm²/h½ and 2.37 ± 0.17 mg/cm²/h½, respectively which were lower when compared to release rate of 2.67 ± 0.07 mg/cm²/h½ from formulation containing 7.5% w/w PG. The best formulation of caffeine gel with good physical appearance and good release rate comprised of 3% caffeine, 0.5% carbopol Ultrez-21 and 7.5% PG.

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