Displaying publications 81 - 100 of 132 in total

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  1. Heidarpour F, Mohammadabadi MR, Zaidul IS, Maherani B, Saari N, Hamid AA, et al.
    Pharmazie, 2011 May;66(5):319-24.
    PMID: 21699064
    The oral route is considered the most patient-convenient means of drug administration. In recent years there has been a tendency to employ smart carrier systems that enable controlled or timed release of a bioactive material, thereby providing a better dosing pattern and minimizing side effects. Nano-encapsulation systems (nanocarriers) offer important advantages over conventional drug delivery techniques. Nanocarriers can protect the drug from chemical/enzymatic degradation and enhance bioavailability. Prebiotics are ideal ingredients for the nano-encapsulation and oral drug delivery due to their natural ability to protect the encapsulated compound in the upper gasterointestinal (GI) tract. Here the potential of prebiotics for oral delivery of drugs and other bioactives is reviewed.
    Matched MeSH terms: Tablets, Enteric-Coated
  2. Al Azzam KM, Saad B, Tat CY, Mat I, Aboul-Enein HY
    J Pharm Biomed Anal, 2011 Dec 15;56(5):937-43.
    PMID: 21873014 DOI: 10.1016/j.jpba.2011.08.007
    A micellar electrokinetic chromatography method for the determination of sumatriptan succinate in pharmaceutical formulations was developed. The effects of several factors such as pH, surfactant and buffer concentration, applied voltage, capillary temperature, and injection time were investigated. Separation took about 5 min using phenobarbital as internal standard. The separation was carried out in reversed polarity mode at 20 °C, 26 kV and using hydrodynamic injection for 10s. Separation was achieved using a bare fused-silica capillary 50 μm×40 cm and background electrolyte of 25 mM sodium dihydrogen phosphate-adjusted with concentrated phosphoric acid to pH 2.2, containing 125 mM sodium dodecyl sulfate and detection was at 226 nm. The method was validated with respect to linearity, limits of detection and quantification, accuracy, precision and selectivity. The calibration curve was linear over the range of 100-2000 μg mL(-1). The relative standard deviations of intra-day and inter-day precision for migration time, peak area, corrected peak area, ratio of corrected peak area and ratio of peak area were less than 0.68, 3.48, 3.28, 2.97 and 2.83% and 2.01, 5.50, 4.46, 4.92 and 4.07%, respectively. The proposed method was successfully applied to the determinations of the analyte in tablet. Forced degradation studies were conducted by introducing a sample of sumatriptan succinate standard solution to different forced degradation conditions using neutral (water), basic (0.1 M NaOH), acidic (0.1 M HCl), oxidative (10% H(2)O(2)) and photolytic (exposure to UV light at 254 nm for 2 h). It is concluded that the stability-indicating method for sumatriptan succinate can be used for the analysis of the drug in various samples.
    Matched MeSH terms: Tablets
  3. Al Azzam KM, Saad B, Makahleah A, Aboul-Enein HY, Elbashir AA
    Biomed Chromatogr, 2010 May;24(5):535-43.
    PMID: 19739243 DOI: 10.1002/bmc.1323
    A micellar electrokinetic chromatography (MEKC) method for the simultaneous determination of the antiviral drugs acyclovir and valacyclovir and their major impurity, guanine, was developed. The influences of several factors (surfactant and buffer concentration, pH, applied voltage, capillary temperature and injection time) were studied. Using tyramine hydrochloride as internal standard, the analytes were all separated in about 4 min. The separation was carried out in reversed polarity mode at 28 degrees C, 25 kV and using hydrodynamic injection (15 s). The separation was effected in a fused-silica capillary 100 microm x 56 cm and a background electrolyte of 20 mM citric acid-1 M Tris solution (pH 2.75), containing 125 mM sodium dodecyl sulphate and detection at 254 nm. The method was validated with respect to linearity, limit of detection and quantification, accuracy, precision and selectivity. Calibration curves were linear over the range 0.1-1 microg/mL (guanine) and from 0.1 to 120 microg/mL for both valacyclovir and acyclovir. The relative standard deviations of intra- and inter-day migration times and corrected peak areas were less than 5.0%. The proposed method was successfully applied to the determination of the analytes in tablets and creams. From the previous study it is concluded that the stability-indicating method developed for acyclovir and valacyclovir can be used for analysis of the drug in various stability samples.
    Matched MeSH terms: Tablets
  4. Zeeshan F, Peh KK, Tan YT
    AAPS PharmSciTech, 2009;10(3):850-7.
    PMID: 19554454 DOI: 10.1208/s12249-009-9278-2
    Compaction of controlled-release coated pellets into tablets is challenging because of the fusion of pellets and the rupturing of coated film. The difficulty in compaction intensifies with the use of extremely water-soluble drugs. Therefore, the present study was conducted to prepare and compact pellets containing pseudoephedrine hydrochloride as an extremely water-soluble model drug. The pellets were produced using an extrusion-spheronization technique. The drug-loaded pellets were coated to extend the drug release up to 12-h employing various polymers, and then they were compressed into tablets using microcrystalline cellulose Ceolus KG-801 as a novel tabletting excipient. The in vitro drug release studies of coated pellets and tablets were undertaken using the USP basket method in dissolution test apparatus I. The amount of drug released was analyzed at a wavelength of 215 nm. The combined coatings of hydroxypropyl methylcellulose and Kollicoat SR-30D yielded 12-h extended-release pellets with drug release independent of pH of dissolution medium following zero-order kinetics. The drug release from the tablets prepared using inert Celous KG-801 granules as tabletting excipient was found faster than that of coated pellets. However, a modification in drug release rate occurred with the incorporation of inert Ceolus KG-801 pellets. The drug dissolution profile from tablets containing 40% w/w each of coated pellets and inert granules along with 20% w/w inert pellets was found to be closely similar to that of coated pellets. Furthermore, the friability, tensile strength, and disintegration time of the tablets were within the USP specifications.
    Matched MeSH terms: Tablets
  5. Chik Z, Basu RC, Pendek R, Lee TC, Mohamed Z
    Int J Clin Pharmacol Ther, 2009 Jun;47(6):413-8.
    PMID: 19473604
    This study was carried out to compare the rate and extent of absorption of a generic salbutamol in oral dosage form (Brethmol, 4 mg) with the proprietary equivalent product (Ventolin, 4 mg), in healthy adult subjects, under fasting conditions. The study was a single dose, randomized, two way crossover study with a four-week washout period. It involved 22 healthy volunteers who received a single dose (4 mg) of the test and the reference products after an overnight fast of at least 10 hours. Blood samples were collected at pre-dose and a serial of 14 samples were collected from each of the subject from 1 h until 48 h post-dose. Plasma concentrations of salbutamol were analyzed using GCMS method. The mean AUC(0-yen) values were 91.26 and 96.45 h.ng/ml for reference and test product, respectively. The mean C(max) values were 12.26 and 12.38 ng/ml and the mean t(max) values were 2.80 and 2.33 hours for reference and test product, respectively. Analysis of variance showed that the 90% confidence intervals on the relative difference of the ratio for the AUC(0-yen) and the C(max) for the test and reference products were contained within the bioequivalence limit (80 - 125%) (C(max): 89.8 - 110.5% and AUC(0-yen): 91.6 - 121.5%). There was no statistically significant difference for the t(max) between the test and reference formulations (p = 0.30). The test formulation was found to be bioequivalent to the reference formulation with regard to AUC(0-yen) and C(max). There was no statistically significant difference in Brethmol and Ventolin t(max). In conclusion, Brethmol and Ventolin are bioequivalent in healthy subjects.
    Matched MeSH terms: Tablets
  6. Nair A, Gupta R, Vasanti S
    Pharm Dev Technol, 2007;12(6):621-5.
    PMID: 18161635
    The present study is an attempt to formulate a controlled-release matrix tablet formulation for alfuzosin hydrochloride by using low viscous hydroxy propyl methyl cellulose (HPMC K-100 and HPMC 15cps) and its comparison with marketed product. Different batches of tablets containing 10 mg of alfuzosin were prepared by direct compression technique and evaluated for their physical properties, drug content, and in vitro drug release. All the formulations had a good physical integrity, and the drug content between the batches did not vary by more than 1%. Drug release from the matrix tablets was carried out for 12 hr and showed that the release rate was not highly significant with different ratios of HPMC K-100 and HPMC15cps. Similar dissolution profiles were observed between formulation F3 and the marketed product throughout the study period. The calculated regression coefficients showed a higher r2 value with zero-order kinetics and Higuchi model in all the cases. Although both the models could be applicable, zero-order kinetics seems to be better. Hence, it can be concluded that the use of low viscous hydrophilic polymer of different grades (HPMC K-100 and HPMC 15cps) can control the alfuzosin release for a period of 12 hr and was comparable to the marketed product.
    Matched MeSH terms: Tablets
  7. Magosso E, Yuen KH, Choy WP, Ling SSN, Ng BH, Ur-Rahman N, et al.
    Med J Malaysia, 2004 Aug;59(3):352-6.
    PMID: 15727381
    The bioavailability of a generic diclofenac sodium sustained release tablet preparation (Zolterol, SR) was compared with the innovator product, Voltaren, SR. Twelve healthy adult male volunteers participated in the study, which was conducted according to a randomized, two-way crossover design with a wash out period of one week. The bioavailability of diclofenac was compared using the parameters area under the plasma concentration-time curve (AUC(0-infinity)), peak plasma concentration (Cmax) and time to reach peak plasma concentration (Tmax). No statistically significant difference was observed for both logarithmically transformed AUC(0-infinity), Cmax values and Tmax value of the two preparations.
    Matched MeSH terms: Tablets
  8. Madan JR, Pawar KT, Dua K
    Int J Pharm Investig, 2015 Apr-Jun;5(2):114-20.
    PMID: 25838997 DOI: 10.4103/2230-973X.153390
    Low aqueous solubility is a major problem faced during formulation development of new drug molecules. Lurasidone HCl (LRD) is an antipsychotic agent specially used in the treatments of schizophrenia and is a good example of the problems associated with low aqueous solubility. Lurasidone is practically insoluble in water, has poor bioavailability and slow onset of action and therefore cannot be given in emergency clinical situations like schizophrenia. Hence, purpose of this research was to provide a fast dissolving oral dosage form of Lurasidone. This dosage form can provide quick onset of action by using the concept of mixed hydrotropy. Initially, solubility of LRD was determined individually in nicotinamide, sodium citrate, urea and sodium benzoate at concentration of 10, 20, 30 and 40% w/v solutions using purified water as a solvent. Highest solubility was obtained in 40% sodium benzoate solution. In order to decrease the individual hydrotrope concentration mixed hydrotropic agents were used. Highest solubility was obtained in 15:20:5 ratio of Nicotinamide + sodium benzoate + sodium citrate. This optimized combination was utilized in the preparation of solid dispersions by using distilled water as a solvent. Solid dispersions were evaluated for X-ray diffraction, differential scanning calorimetry and Fourier-transform infrared to show no drug-hydrotropes interaction has occurred. This solid dispersion was compressed to form fast dissolving tablets. Dissolution studies of prepared tablets were done using USP Type II apparatus. The batch L3 tablets show 88% cumulative drug release within 14 min and in vitro dispersion time was 32 min. It was concluded that the concept of mixed hydrotropic solid dispersion is novel, safe and cost-effective technique for enhancing the bioavailability of poorly water-soluble drugs. The miraculous enhancement in solubility and bioavailability of Lurasidone is clear indication of the potential of mixed hydrotropy to be used in future for other poorly water-soluble drugs in which low bioavailability is a major concern.
    Matched MeSH terms: Tablets
  9. Yuen KH, Wong JW, Billa N, Julianto T, Toh WT
    Int J Clin Pharmacol Ther, 1999 Jul;37(7):319-22.
    PMID: 10442505
    The bioavailability of a generic preparation of metformin (Diabetmin from Hovid Sdn Bhd) was evaluated in comparison with a proprietary product (Glucophage from Lipha Pharma Ltd., UK).
    Matched MeSH terms: Tablets
  10. Bin LK, Helaluddin ABM, Islam Sarker MZ, Mandal UK, Gaurav A
    Pak J Pharm Sci, 2020 Mar;33(2):551-559.
    PMID: 32276897
    Orally disintegrating tablet (ODT) is a friendly dosage form that requires no access to water and serves as a solution to non-compliance. There are many co-processed adjuvants available in the market. However, there is no single product possesses all the ideal characteristics such as good compressibility, fast disintegration and good palatability for ODT application. The aim of this research was to produce a xylitol-starch base co-processed adjuvant which is suitable for ODT application. Two processing methods namely wet granulation and freeze drying were used to compare the characteristics of co-processed adjuvant comprising of xylitol, starch and crospovidone XL-10 mixed at various ratios. The co-processed excipients were compressed into ODT and physically characterized for powder flow, particle size, hardness, thickness, weight, friability, in-vitro disintegration time and in-situ disintegration time, lubricant sensitivity, dilution potential, Fourier transform infrared spectroscopy, scanning electronic microscopy and x-ray diffraction analysis. Formulation F6 was selected as the optimum formulation due to the fastest in-vitro (135.33±11.52 s) and in-situ disintegration time (88.67±13.56s) among all the formulations (p<0.05). Increase in starch component decreases disintegration time of ODT. The powder flow fell under the category of fair flow. Generally, it was observed that freeze drying method produced smaller particle size granules compared to wet granulation method. ODT produced from freeze drying method had shorter disintegration time compared to ODT from wet granulation batch. In conclusion, a novel co-processed excipient comprised of xylitol, starch and crospovidone XL-10, produced using freeze drying method with fast disintegration time, good compressibility and palatability was developed and characterized. The co-processed excipient is suitable for ODT application.
    Matched MeSH terms: Tablets
  11. Bukhari NI, Zafar A, Shamsi Wu, Bashir MA, Mirza AA
    Therapie, 2005 Mar-Apr;60(2):167-73.
    PMID: 15969319
    AIM: The bioequivalence of aspirin from two enteric-coated brands, Nu-seals and Loprin, identified as the reference (R) and test (T) products, respectively, was assessed.

    METHODS: A two-period randomised crossover design with a washout interval of 15 days was used in this study. The study results were determined in 16 healthy volunteers, all males with ages ranging from 19-28 (23.33 +/- 3.74) years and bodyweights of 52-92 (65.89 +/- 11.39) kg. After oral ingestion of 150mg of the either brand with 200 mL of water, serial blood samples were obtained over a period of 24 hours. Plasma, harvested from blood was analysed for the concentration of salicylic acid, a deacetylated metabolite of aspirin, by a validated high performance liquid chromatography (HPLC) method. Pharmacokinetic parameters were determined for both formulations by an interactive computer-assisted PK II procedure. A general linear model for repeated measures and 90% confidence intervals (CI) was employed to assess the sequence of treatment effects and to exclude differences between the parameters due to the product and period of administration, respectively.

    RESULTS: The observed 90% CI ratios (Loprin/Nu-seals) for peak concentration, time to reach the peak and area under the plasma-concentration time curve from zero to infinity of 1.03,1.08; 1.04,1.05 and 1.01,1.15, respectively, were within the bioequivalence range (0.80,1.25) stipulated by the US Food and Drug Administration.

    CONCLUSION: On the basis of the findings, the test (Loprin) and reference drug (Nu-seals) were deemed bioequivalent.
    Matched MeSH terms: Tablets, Enteric-Coated
  12. Mawazi SM, Al-Mahmood SMA, Chatterjee B, Hadi HA, Doolaanea AA
    Pharmaceutics, 2019 Sep 20;11(10).
    PMID: 31547112 DOI: 10.3390/pharmaceutics11100488
    This study aimed to develop a carbamazepine (CBZ) sustained release formulation suitable for pediatric use with a lower risk of precipitation. The CBZ was first prepared as sustained release microparticles, and then the microparticles were embedded in alginate beads, and finally, the beads were suspended in a gel vehicle. The microparticles were prepared by a solvent evaporation method utilizing ethyl cellulose as a sustained release polymer and were evaluated for particle size, encapsulation efficiency, and release profile. The beads were fabricated by the dropwise addition of sodium alginate in calcium chloride solution and characterized for size, shape, and release properties. The gel was prepared using iota carrageenan as the gelling agent and evaluated for appearance, syneresis, drug content uniformity, rheology, release profile, and stability. The microparticles exhibited a particle size of 135.01 ± 0.61 µm with a monodisperse distribution and an encapsulation efficiency of 83.89 ± 3.98%. The beads were monodispersed with an average size of 1.4 ± 0.05 mm and a sphericity factor of less than 0.05. The gel was prepared using a 1:1 ratio (gel vehicle to beads) and exhibited no syneresis, good homogeneity, and good shear-thinning properties. The release profile from the beads and from the gel was not significantly affected, maintaining similarity to the tablet form. The gel properties were maintained for one month real time stability, but the accelerated stability showed reduced viscosity and pH with time. In conclusion, CBZ in a gel sustained release dosage form combines the advantages of the suspension form in terms of dosing flexibility, and the advantages of the tablet form in regards to the sustained release profile. This dosage form should be further investigated in vivo in animal models before being considered in clinical trials.
    Matched MeSH terms: Tablets
  13. Navedur Rehman, Chin Chwen Ch’ng, Thavin Kumar Mathana Sundram, Eugenie Sin Sing Tan, Chew Kek Lee, Chung Keat Tan3
    MyJurnal
    Introduction: Acne vulgaris is a chronic inflammatory dermatosis caused by Propionibacterium acnes. Clinicians are constantly attempting to discover the best antibiotic regimes in treating acne vulgaris. This study compares two regimens in terms of efficacy, tolerability, compliance and recurrence rate to make recommendation on which is the best regime. Methods: An open-labelled prospective randomized investigator-blinded interventional study was carried on moderate acne vulgaris patients. Patients were assigned to treatment arm at enrolment followed by fol- low-up and maintenance visits. Demographic data were collected at enrolment and questionnaire enquiring acne condition, general health and quality of life impairment were filled at every visit followed by blinded dermatologist assessment. Antibiotic tablets were provided based on assigned arm until follow-up 3. Results: 26 mild acne vulgaris patients aged 17 to 29 years were recruited. Physician assessment based on GAGS and photo assessment analysis showed an overall significant change (p0.05) were found between regimens. Similarly, patient self-perceived assessment and CADI assessment also showed overall significant changes (p
    Matched MeSH terms: Tablets
  14. Sheshala R, Khan N, Darwis Y
    Chem Pharm Bull (Tokyo), 2011;59(8):920-8.
    PMID: 21804234
    The aims of the present research were to mask the intensely bitter taste of sumatriptan succinate and to formulate orally disintegrating tablets (ODTs) of the taste masked drug. Taste masking was performed by coating sumatriptan succinate with Eudragit EPO using spray drying technique. The resultant microspheres were evaluated for thermal analysis, yield, particle size, entrapment efficiency and in vitro taste masking. The tablets were formulated by mixing the taste masked microspheres with different types and concentrations of superdisintegrants and compressed using direct compression method followed by sublimation technique. The prepared tablets were evaluated for weight variation, thickness, hardness, friability, drug content, water content, in vitro disintegration time and in vitro drug release. All the tablet formulations disintegrated in vitro within 37-410 s. The optimized formulation containing 5% Kollidon CL-SF released more than 90% of the drug within 15 min and the release was comparable to that of commercial product (Suminat®). In human volunteers, the optimized formulation was found to have a pleasant taste and mouth feel and disintegrated in the oral cavity within 41 s. The optimized formulation was found to be stable and bioequivalent with Suminat®.
    Matched MeSH terms: Tablets
  15. Abdullah SN, Mohmad Sabere AS
    J Pharm Bioallied Sci, 2020 12 21;13(1):143-147.
    PMID: 34084061 DOI: 10.4103/jpbs.JPBS_463_20
    One of the major concerns in any pharmacological treatment is the patients' adherence to medication. However, different types of ocular dosage forms might result in different response and compliance from the patients. This study investigated and compared public willingness on different types of dosage forms available for ocular treatment. The study also evaluated their willingness on new approach for the treatment based on their knowledge, attitude, and perception. This study was conducted between October and December 2017 through a set of questionnaires applied to 90 respondents between the age of 18 and 60 years who lived in Muar and Kuantan, Malaysia. The results were analyzed using SPSS software version 22.0 including inferential and descriptive statistics. There was no significant difference in the knowledge level between all age groups towards different types of dosage forms available; eye drops (P = 0.09), eye ointment (P = 0.252), medicated contact lens (P = 0.05), ocular mini-tablets (P = 0.06), and ocular inserts (P = 0.075). There is a variation of results among the public towards different types of dosage forms with their willingness to try conventional and novel approach. Eye drops show the highest willingness followed by eye ointment (less willingness). However, most of them showed no willingness towards medicated contact lens, ocular mini-tablets, and ocular insert. This research hopes to provide an overview on the development process of new formulation and dosage forms based on the patients' willingness level in an attempt to increase patient compliance.
    Matched MeSH terms: Tablets
  16. Siti Khatijah, A.R., Rosnah, S.
    MyJurnal
    Background : Anemia in pregnancy is a worldwide problem. Ministry of Health Malaysia has conducted prophylaxis program to distribute hematinic pills to pregnant women since 3 decades ago.
    Methodology : A cross sectional study was conducted among pregnant women who attended government health clinics in Johor Bahru district to assess the prevalence of taking iron tablet and factors associated with it by using a structured questionnaire.
    Result : Prevalence of respondents taking ferrous pill daily was 68.6%. Anemia prevalence found in this study was 37.5%. Majority of the respondents did not take pills regularly said their reason as forgotten(54.0%), side effects caused by taking pill (39.3%) and did not like the taste (6.7%). The haemoglobin mean was directly inclined with frequency of ferrous pill intake. The significant associated factor in taking iron pill was only frequency of drinking tea. Multivariate logistic regression analyses revealed that drinking tea was the only factor that contributing to iron pills consumption.
    Conclusion : Education is the most important factor in improving adherence to iron pill. Besides that, motivation and behaviour modification of pregnant women also needs to be taken into account.
    Matched MeSH terms: Tablets
  17. Low, Qin Jian, Chew, Soo Foong
    MyJurnal
    Both metformin and gliclazide have been used extensively in the management of type II diabetes mellitus. Metformin and gliclazide overdose can lead to severe hypoglycaemia refractory to intravenous (IV) dextrose rescue therapy. A 21-year-old man complained of vomiting and felt dizzy after four hours of taking 70 tablets of Metformin 500 mg and 40 tablets of Gliclazide 80 mg. He had major depressive disorder and wanted to commit suicide. He was given IV Dextrose 50% 50 cc immediately. Octreotide had been used successfully to reverse the refractory hypoglycaemia caused by gliclazide overdose. Unfortunately, he developed severe lactic acidosis with acute kidney injury. Dialysis had been done by continuous venovenous haemodiafiltrationa and intravenous sodium bicarbonate 8.4% infusion was given. However, the patient succumbed due to the severe lactic acidosis and kidney failure despite of urgent dialysis. Octreotide infusion helps in preventing refractory hypoglycaemia secondary to sulfonylurea overdose by inhibit calcium-mediated insulin release. Metformin overdose causes severe lactic acidosis due to conversion of glucose to lactate. Sodium bicarbonate therapy in metformin induced lactic acidosis is also controversial. Though sulfonylurea and metformin are the most commonly-prescribed anti-hypoglycaemic agents, thus during prescribing everyone has to be careful about the overdoses and side effects of these drugs.
    Matched MeSH terms: Tablets
  18. Liew KB, Peh KK
    Pak J Pharm Sci, 2018 Nov;31(6):2515-2522.
    PMID: 30473526
    A stability-indicating HPLC-UV method for the simultaneous determination of sildenafil citrate and dapoxetine hydrochloride in solution and tablet was developed. The mobile phase was comprised of acetonitrile and 0.2M ammonium acetate buffer. The analyte was eluted at 3.392min and 7.255min for sildenafil citrate and dapoxetine HCl respectively using gradient system at a flow rate of 1.5mL/min. The theoretical plates count was>2000, tailing factor
    Matched MeSH terms: Tablets
  19. Lai JML, Yang SL, Avoi R
    J Glob Infect Dis, 2019 3 1;11(1):2-6.
    PMID: 30814828 DOI: 10.4103/jgid.jgid_50_18
    Introduction: Conventionally, a combination of four separate drugs (ethambutol, isoniazid, rifampicin, and pyrazinamide [EHRZ]) is the first-line pharmacotherapy for pulmonary tuberculosis (TB). In recent years, fixed-dose combination (FDC) formulation, where a single tablet contains the active ingredients of four aforementioned drugs, is gaining popularity due to its ease of administration.

    Objective: To compare the real-world effectiveness of EHRZ and FDC treatment groups on a cohort registry by investigating the sputum conversion rate and treatment outcomes of both groups.

    Methods: A total of 11,489 patients' data were extracted from the Sabah TB registry between January 2012 and June 2016, including EHRZ (n = 4188) and FDC (n = 7301) patients. Then, 1:1 propensity score matching was adopted to reduce the baseline bias. Caliper matching was conducted with maximum tolerance score set at 0.001. Confounders included in the propensity score matching were gender, nationality, diabetes, HIV status, smoking status, and chest X-ray status. Successful matching provided 4188 matched pairs (n = 8376) for final analysis.

    Results: In this matched cohort of 4188 pairs, the 2-month sputum conversion rate of FDC group was significantly higher than the EHRZ group (96.3% vs. 94.3%; P < 0.001) whereas 6-month sputum conversion of both groups showed no significant difference. Treatment outcomes such as noncompliance rate, failure rate, and success rate have no significant difference (P > 0.05) in both the treatment groups. There was an incidental finding of reduced death rate among FDC group compared to the EHRZ group (0.2% vs. 0.5%; P = 0.034).

    Conclusion: The FDC formulation has better sputum conversion rate at 2 months compared to conventional EHRZ regime as separate-drug formulation. It was also observed that FDC has a slight protective effect against all-cause death among TB patients. This protective effect of FDC, however, still needs to be proven further.

    Matched MeSH terms: Tablets
  20. Ang HH, Lee EL, Matsumoto K
    Hum Exp Toxicol, 2003 Aug;22(8):445-51.
    PMID: 12948085 DOI: 10.1191/0960327103ht382oa
    In Malaysia, the phase 3 registration for traditional medicines was implemented on 1 January 1992 under the Control of Drugs and Cosmetics Regulation 1984, emphasizing quality, efficacy and safety (including the detection of the presence of heavy metals) in all pharmaceutical dosage forms of traditional medicine preparations. Therefore, a total of 100 products in various pharmaceutical dosage forms of a herbal preparation, were analysed for lead content using atomic absorption spectrophotometer. Results showed that 8% (eight products) possessed 10.64-20.72 ppm of lead, and therefore, do not comply with the quality requirement for traditional medicines in Malaysia. One of these products, M-Tongkat Ali (exhibited 10.64 +/-0.37 ppm of lead), was in fact already registered with the DCA Malaysia. The rest, Sukarno Tongkat Ali, Eurycoma Madu, Super Pill Tongkat Ali, Force Pill Tongkat Ali, Tender Pill Tongkat Ali, Super Pill Tongkat Ali Plus and Great Pill Tongkat Ali Plus have not registered with the DCA Malaysia and exhibited 12.24-20.72 ppm of lead. Although this study showed that only 92% of the products complied with the quality requirement for traditional medicines in Malaysia, however, they cannot be assumed safe from lead contamination because of batch-to-batch inconsistency.
    Matched MeSH terms: Tablets
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