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Bioequivalence assessment of two enteric-coated aspirin brands, Nu-Seals and Loprin, after a single oral dose of 150 mg in healthy male adults

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
Solubility enhancement effect at absorption site on bioavailability of ritonavir using liquisolid technique

Bonthagarala B, Dasari V, Kotra V

Ther Deliv, 2019 May 01;10(5):295-310.
PMID: 31094300 DOI: 10.4155/tde-2019-0020

Aim: The present study revolved around determining the effect of increase in the solubility of these drugs at the absorption site using ritonavir as a drug model. Materials & methods: Ritonavir per-oral tablets were prepared using versatile and nonionic surfactants having high solubilization rate, which were further marked with high rate of dissolution. The high rate of dissolution formula applied to the solid state characterization by means of transition electron microscopy, differential scanning calorimetry, scanning electron microscopy, X-ray diffraction and infrared spectroscopy. Results & conclusion: The drug bioavailability was seen to increase expressively by administration of liquisolid tablets as compared with conventional tablets.

Matched MeSH terms: Tablets
Efficacy of a Bacillus thuringiensis israelensis tablet formulation, vectobac DT, for control of dengue mosquito vectors in potable water containers

Benjamin S, Rath A, Fook CY, Lim LH

Southeast Asian J. Trop. Med. Public Health, 2005 Jul;36(4):879-92.
PMID: 16295540

VectoBac DT, a tablet formulation of Bacillus thuringiensis israelensis (Bti) was evaluated for the potential control of dengue vectors in various types of potable water containers. On introduction to containers, the tablet sinks to the bottom and the Bti toxins are found concentrated at the sides and the base, while the treated water column is free of Bti toxins within 24 hours after tablet introduction. In a simulated study, earthen, HDPE and plastic containers were kept covered and laboratory-bred larvae were introduced to determine the control by the tablet. The efficacy and persistence of the tablet, with a control of > 90%, was significantly longer in earthen containers in comparison to the HDPE and plastic containers. Efficacy and persistence were observed in earthen containers for a minimum period of 5.5 months (166 days) both without water replenishment and with weekly, 50% water volume, replenishment, and for a maximum period of 2.2 months (66 days) with daily, 50% water volume, replenishment. In plastic and HDPE containers, the tablet activity had a persistence of 2.1 months (63 days) without water replenishment and 1.8 months (54 days) with weekly water replenishment. The efficacy and persistence of the VectoBac DT was significantly longer in the earthen containers, with or without regularly treated water exchange, due to the Bti toxins being embedded in the porous earthen container surfaces, which protects them from rapid degradation. Lesser toxin amounts are removed from the water column during water exchange. The efficacy of VectoBac DT was also evaluated for the control of natural infestation of Aedes larvae which were resistant to temephos at the WHO diagnostic dosage of 0.012 mg/l. The tablet significantly reduced the pupal density by 8 fold in earthen containers for 67 days and 5 fold in HDPE containers for 55 days in comparison to untreated containers (p < 0.05). However, the tablet was effective for a shorter period of 25 days post-tablet-introduction due to fungal infestation in the treated plastic containers. There is a need to determine the capacity of the VectoBac DT to reduce the dengue vector population to a threshold which will prevent dengue outbreaks in dengue endemic areas.

Matched MeSH terms: Tablets
Fulltext Glycaemic control and cost analysis when changing from gliclazide co-administered with metformin to pre-combined glibenclamide-metformin tablets in type 2 diabetes mellitus

Lim PC, Lim SL, Oiyammaal C

Med J Malaysia, 2012 Feb;67(1):21-4.
PMID: 22582544

Type-2 diabetes mellitus (T2DM) patients who were on gliclazide co-administered with metformin were changed to pre-combined glibenclamide-metformin tablets in the Endocrine Clinic, Penang Hospital. We conducted a retrospective study to evaluate the differences in glycaemic control and treatment cost following the change. Eighty patients (60% females) with a mean age of 55 years old were studied. Mean glycosylated haemoglobin (HbAlc) reduction was -0.92% (p<0.01) and -0.83% (p<0.01) after three and six months respectively. Patients with baseline HbA1c > or =8% had greater reduction in mean HbA1c (-1.36%) after six months. The treatment cost per month was reduced by 45% at 3 months (p<0.01)) and 44% at 6 months (p<0.01). The change to pre-combined glibenclamide-metformin tablets resulted in significant improvement in glycaemia and reduction in treatment cost.

Matched MeSH terms: Tablets
Fulltext Comparative bioavailability study of a generic sustained release diclofenac sodium tablet

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
Fulltext Tell tale of tablets in bronchus

Shimpi T, Chawla A, Shikhare S

Med J Malaysia, 2015 Feb;70(1):36-7.
PMID: 26032528

Foreign body (FB) aspiration is an emergency of concern at all ages. However, in adults, it can present with atypical symptoms such as shortness of breath, wheezing or rarely cyanosis. Aspiration of oral medications is seen in the elderly population with impairment of protective airway mechanism. Treatment of choice is endoscopic removal of the foreign body. We report such a case of foreign body aspiration (potassium chloride tablet), diagnosed on imaging and subsequently developed bronchostenosis. There are a very few reported cases of oral potassium supplement aspiration and associated complications in the literature.

Matched MeSH terms: Tablets
A tablet test for haematuria and its application in anticoagulant therapy

WELLS R

Med J Malaya, 1957 Dec;12(2):435-9.
PMID: 13515875
Matched MeSH terms: Tablets*
Fulltext "VisionTouch Phone" for the Blind

Yong R

Malays J Med Sci, 2013 Oct;20(5):1-4.
PMID: 24643391

Our objective is to enable the blind to use smartphones with touchscreens to make calls and to send text messages (sms) with ease, speed, and accuracy. We believe that with our proposed platform, which enables the blind to locate the position of the keypads, new games and education, and safety applications will be increasingly developed for the blind. This innovative idea can also be implemented on tablets for the blind, allowing them to use information websites such as Wikipedia and newspaper portals.

Matched MeSH terms: Tablets
Quality of amoxicillin/clavulanic acid oral formulations for intended veterinary use in the UK, Malaysia, Serbia and Thailand

Pelligand L, Baker D, Sivagurunathan A, Kovačević Z, Suemanotham N, Stair JL, et al.

J Small Anim Pract, 2023 Oct;64(10):626-634.
PMID: 37340896 DOI: 10.1111/jsap.13648

OBJECTIVES: Amoxicillin/clavulanate is the most commonly used oral antimicrobial drug in companion animals. The objective of the study was to detect types and frequency of deficits in the quality of veterinary oral formulations of amoxicillin/clavulanate in various countries.
MATERIALS AND METHODS: In a prospective study with purposive sampling, amoxicillin/clavulanate tablet formulations for canine use were collected in four countries (wholesalers or veterinary practice) and shipped to a central bioanalytical laboratory. Twenty-four samples were collected from the UK (nine), Malaysia (nine), Serbia (four) and Thailand (two), yielding 18 different formulations (10 veterinary). Packaging inspection, tablet disintegration and content assay were conducted (validated high-performance liquid chromatography with ultra-violet detection); content was acceptable when within the 90% to 120% pre-specified range (US Pharmacopeia).
RESULTS: Secondary packaging was present for 13 of 24 samples and primary packaging integrity was verified for all but one sample. Amoxicillin trihydrate/potassium clavulanate label ratio was 4:1, except for three formulations (2:1). Tablet dose strength ranged from 250 to 625 mg. All formulations contained both analytes. For amoxicillin, two of 24 samples were out of specification with 72.8% (Malaysia) and 82.3% (Thailand) of labelled content. For clavulanate, four of 24 samples were out of specification with 46.9% (Serbia), 79.0% (UK), 84.3% (Serbia) and 86.5% (Thailand) of labelled content. One formulation (Thailand) failed for both analytes.
CLINICAL SIGNIFICANCE: Antimicrobial formulations of substandard quality have negative consequences for efficacy in patients and potentially promote antimicrobial resistance. There was evidence of substandard formulations in all countries, not only for amoxicillin but especially for clavulanate; this could compromise equitable access to acceptable quality essential veterinary medicines worldwide.

Matched MeSH terms: Tablets
Single-centre study of therapeutic drug monitoring of posaconazole in lung transplant recipients: factors affecting trough plasma concentrations

Jeong W, Snell GI, Levvey BJ, Westall GP, Morrissey CO, Wolfe R, et al.

J Antimicrob Chemother, 2018 Mar 01;73(3):748-756.
PMID: 29211913 DOI: 10.1093/jac/dkx440

Objectives: This study describes therapeutic drug monitoring (TDM) of posaconazole suspension and modified release (MR) tablets in lung transplant (LTx) recipients and evaluates factors that may affect posaconazole trough plasma concentration (Cmin).
Methods: A single-centre, retrospective study evaluating posaconazole Cmin in LTx recipients receiving posaconazole suspension or MR tablets between January 2014 and December 2016.
Results: Forty-seven LTx patients received posaconazole suspension, and 78 received the MR tablet formulation; a total of 421 and 617 Cmin measurements were made, respectively. Posaconazole was concurrently administered with proton pump inhibitor in ≥ 90% of patients. The median (IQR) of initial posaconazole Cmin following 300 mg daily of posaconazole tablet was significantly higher than that of 800 mg daily of posaconazole suspension [1.65 (0.97-2.13) mg/L versus 0.81 (0.48-1.15) mg/L, P

Matched MeSH terms: Tablets
Fulltext Health innovations in patient decision support: Bridging the gaps and challenges

Ng CJ, Lee YK, Lee PY, Abdullah KL

Australas Med J, 2013;6(2):95-9.
PMID: 23483776 DOI: 10.4066/AMJ.2013.1655

Patient decision aids (PDAs) help to support patients in making an informed and value-based decision. Despite advancement in decision support technologies over the past 30 years, most PDAs are still inaccessible and few address individual needs. Health innovation may provide a solution to bridge these gaps. Information and computer technology provide a platform to incorporate individual profiles and needs into PDAs, making the decision support more personalised. Health innovation may enhance accessibility by using mobile, tablet and Internet technologies; make risk communication more interactive; and identify patient values more effectively. In addition, using databases to capture patient data and the usage of PDAs can help: developers to improve PDAs' design; clinicians to facilitate the decisionmaking process more effectively; and policy makers to make shared decision making more feasible and cost-effective. Health innovation may hold the key to advancing PDAs by creating a more personalised and effective decision support tool for patients making healthcare decisions.

Matched MeSH terms: Tablets
Chloroquine polymeric membrane electrodes: Development and applications

Saad B, Kanapathy K, Ahmad MN, Hussin AH, Ismail Z

Talanta, 1991 Dec;38(12):1399-402.
PMID: 18965315

Three main types of PVC solvent polymeric membrane ion-selective electrodes for chloroquine are described. They are based on three ion-pairing agents namely dipicrylamine (DPA), tetraphenylborate (TPB) or tetrakis(4-chlorophenyl)borate (TCPB) with either dioctylphenyl phosphonate (DOPP) or trioctyl phosphate (TOP) solvent mediator. All electrodes exhibit Nernstian responses, fast dynamic response times and a wide useful pH range. The best all-round electrode is based on TPB and TOP plasticizing solvent mediators with a limit of detection of 7.1 x 10(-6)M and was utilized for the assay of chloroquine in tablets. Direct potentiometric determinations with either the analyte addition method or the normal calibration method gave results comparable to the official method.

Matched MeSH terms: Tablets
Fulltext Bioequivalence evaluation of two different formulations of ciprofloxacin tablets in healthy volunteers

Hassan Y, Alfadly SO, Azmin MN, Peh KK, Tan TF, Noorizan AA, et al.

Singapore Med J, 2007 Sep;48(9):819-23.
PMID: 17728962

A bioequivalence study of two oral formulations of 500 mg tablets of ciprofloxacin (RAZA Pharmaniaga, Malaysia) as test and Ciprobay (Bayer AG, Germany) as reference, was carried out in 24 healthy human volunteers. Each volunteer received a single dose of ciprofloxacin.

Matched MeSH terms: Tablets
Fulltext SenseCrypt: A Security Framework for Mobile Crowd Sensing Applications

Pius Owoh N, Mahinderjit Singh M

Sensors (Basel), 2020 Jun 09;20(11).
PMID: 32526843 DOI: 10.3390/s20113280

The proliferation of mobile devices such as smartphones and tablets with embedded sensors and communication features has led to the introduction of a novel sensing paradigm called mobile crowd sensing. Despite its opportunities and advantages over traditional wireless sensor networks, mobile crowd sensing still faces security and privacy issues, among other challenges. Specifically, the security and privacy of sensitive location information of users remain lingering issues, considering the "on" and "off" state of global positioning system sensor in smartphones. To address this problem, this paper proposes "SenseCrypt", a framework that automatically annotates and signcrypts sensitive location information of mobile crowd sensing users. The framework relies on K-means algorithm and a certificateless aggregate signcryption scheme (CLASC). It incorporates spatial coding as the data compression technique and message query telemetry transport as the messaging protocol. Results presented in this paper show that the proposed framework incurs low computational cost and communication overhead. Also, the framework is robust against privileged insider attack, replay and forgery attacks. Confidentiality, integrity and non-repudiation are security services offered by the proposed framework.

Matched MeSH terms: Tablets
Fulltext Formulation development and optimization of sustained release matrix tablet of Itopride HCl by response surface methodology and its evaluation of release kinetics

Bose A, Wong TW, Singh N

Saudi Pharm J, 2013 Apr;21(2):201-13.
PMID: 23960836 DOI: 10.1016/j.jsps.2012.03.006

The objective of this present investigation was to develop and formulate sustained release (SR) matrix tablets of Itopride HCl, by using different polymer combinations and fillers, to optimize by Central Composite Design response surface methodology for different drug release variables and to evaluate drug release pattern of the optimized product. Sustained release matrix tablets of various combinations were prepared with cellulose-based polymers: hydroxy propyl methyl cellulose (HPMC) and polyvinyl pyrolidine (pvp) and lactose as fillers. Study of pre-compression and post-compression parameters facilitated the screening of a formulation with best characteristics that underwent here optimization study by response surface methodology (Central Composite Design). The optimized tablet was further subjected to scanning electron microscopy to reveal its release pattern. The in vitro study revealed that combining of HPMC K100M (24.65 MG) with pvp(20 mg)and use of LACTOSE as filler sustained the action more than 12 h. The developed sustained release matrix tablet of improved efficacy can perform therapeutically better than a conventional tablet.

Matched MeSH terms: Tablets
Fulltext Development and evaluation of Ketoprofen sustained release matrix tablet using Hibiscus rosa-sinensis leaves mucilage

Kaleemullah M, Jiyauddin K, Thiban E, Rasha S, Al-Dhalli S, Budiasih S, et al.

Saudi Pharm J, 2017 Jul;25(5):770-779.
PMID: 28725150 DOI: 10.1016/j.jsps.2016.10.006

Currently, the use of natural gums and mucilage is of increasing importance in pharmaceutical formulations as valuable drug excipient. Natural plant-based materials are economic, free of side effects, biocompatible and biodegradable. Therefore, Ketoprofen matrix tablets were formulated by employing Hibiscus rosa-sinensis leaves mucilage as natural polymer and HPMC (K100M) as a synthetic polymer to sustain the drug release from matrix system. Direct compression method was used to develop sustained released matrix tablets. The formulated matrix tablets were evaluated in terms of physical appearance, weight variation, thickness, diameter, hardness, friability and in vitro drug release. The difference between the natural and synthetic polymers was investigated concurrently. Matrix tablets developed from each formulation passed all standard physical evaluation tests. The dissolution studies of formulated tablets revealed sustained drug release up to 24 h compared to the reference drug Apo Keto® SR tablets. The dissolution data later were fitted into kinetic models such as zero order equation, first order equation, Higuchi equation, Hixson Crowell equation and Korsmeyer-Peppas equation to study the release of drugs from each formulation. The best formulations were selected based on the similarity factor (f2) value of 50% and more. Through the research, it is found that by increasing the polymers concentration, the rate of drug release decreased for both natural and synthetic polymers. The best formulation was found to be F3 which contained 40% Hibiscus rosa-sinensis mucilage polymer and showed comparable dissolution profile to the reference drug with f2 value of 78.03%. The release kinetics of this formulation has shown to follow non-Fickian type which involved both diffusion and erosion mechanism. Additionally, the statistical results indicated that there was no significant difference (p > 0.05) between the F3 and reference drug in terms of MDT and T50% with p-values of 1.00 and 0.995 respectively.

Matched MeSH terms: Tablets
Fulltext Comparative pharmacokinetics of a proliposome formulation of Ginkgo biloba extract and Ginaton in rats by a sensitive ultra performance liquid chromatography-tandem mass spectrometry method

Zheng B, Xing G, Bi Y, Yan G, Wang J, Cheng Y, et al.

Saudi J Biol Sci, 2016 Jan;23(1):54-65.
PMID: 26858539 DOI: 10.1016/j.sjbs.2015.08.009

As a novel oral drug delivery system, proliposome was applied to improve the solubility of active components of Ginkgo biloba extract (GbE). There are currently few reports focusing on the pharmacokinetic characteristics of proliposome of GbE (GbP). A rapid and sensitive ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for the simultaneous quantification of active components of GbP and a commercial tablet product (Ginaton) in rat plasma was developed and successfully validated. The method was applied to the comparative pharmacokinetic evaluation of GbP and Ginaton in rat plasma. The results indicated that GbP has a significant effect on absorption, elimination and bioavailability of flavonoids and terpenoid lactones in comparison with Ginaton. The obtained results would be helpful for evaluating the absorption mechanism in the gastrointestinal tract in pharmacokinetic level and guiding the development of the novel oral drug delivery system.

Matched MeSH terms: Tablets
Sifat fizikal dan kajian in vitro tablet matriks pelepasan tertahan ketoprofen

Ibrahim Ijang, Mohd Cairul Iqbal Mohd Amin, Bukhori Abu Bakar

Sains Malaysiana, 2010;39.

Penggunaan formulasi tablet pelepasan tertahan untuk dadah anti-inflamatori bukan steroid (DAIBS) seperti aspirin berupaya melindungi lapisan perut dari kesan buruk jus asid tubuh. Kajian ini dilakukan untuk menilai keberkesanan formulasi tablet matriks pelepasan tertahan dengan kepelbagaian kepekatan polimer bersama ketoprofen sebagai model. Tablet dibangunkan dengan menggunakan kaedah granulasi basah yang terdiri daripada polimer hidrofilik (hidroksipropil metilselulosa), polimer hidrifobik bersandar pada pH (Eudragit L100-55) dan polimer tak bersandar pada pH (Eudragit R100) sebagai bahan asas pembentukan matriks pada kepekatan 10, 20 dan 30%b/b. Semua formulasi dimampatkan dengan menggunakan mesin pentabletan yang mempunyai penebuk berbentuk cembung bersaiz 10 mm. Tablet yang terhasil diuji daripada segi keseragaman berat, kekerasan, kerapuhan, ketebalan, peratus kandungan dadah dan kajian pelepasan in vitro menggunakan kaedah BP 2007. Hasil menunjukkan kadar pelepasan dadah dikawal oleh jenis dan kepekatan polimer di dalam formulasi matriks. Secara umumnya peningkatan kepekatan kandungan polimer di dalam tablet matriks didapati mengurangkan kadar pelepasan dadah. Perbandingan polimer melalui kepekatan yang sama menggunakan t50%, pula mendapati terdapat perbezaan statistik bermakna (p<0.05) pada kadar pelepasan dadah. Berdasarkan kepada pelepasan dadah dalam kajian in vitro, polimer hidrofobik bersandar pada pH (Eudragit L100-55) menunjukkan profil pelepasan dadah secara tertib sifar yang terbaik berbanding polimer yang lain.

Matched MeSH terms: Tablets
Modeling of the dissolution kinetics of arbutus wild berries-based tablets as evaluated by electric conductivity

Tounsia Abbas-Aksil, Salem Benamara

Sains Malaysiana, 2015;44:301-308.

Lyophilized powder (LP) from Algerian arbutus wild berries (Arbutus unedo L.) was obtained. This present paper reports about the dissolution (releasing) properties of LP-based tablets, evaluated through the electric conductivity (EC) of distilled water which is employed as surrounding medium, at three different temperatures (291, 298 and 309 K). In addition to this, secondary physicochemical characteristics such as elementary analysis, color and compressibility were evaluated. Regarding the modeling of ionic transfer, among the three tested models, namely Peleg, Singh et al. and Singh and Kulshestha, the latter seems to be the most appropriate (R2 = 0.99), particularly in the case of compacted tablets under 2000 Pa. The temperature dependence of the dissolution process was also studied applying Arrhenius equation (R2>0.8) which allowed to deduce the activation energy, ranging from 18.7 to 21.4 kJ.mol-1 according to the model and compression force employed.

Matched MeSH terms: Tablets
Bacterial cellulose film coating as drug delivery system: physicochemical, thermal and drug release properties

Mohd Cairul Iqbal Mohd Amin, Abadi Gumah Abadi, Naveed Ahmad, Haliza Katas, Jamia Azdina Jamal

Sains Malaysiana, 2012;41:561-568.

There has been an increasing interest in the use of natural materials as drug delivery vehicles due to their biodegradability, biocompatibility and ready availability. These properties make bacterial cellulose (BC), from nata de coco, a promising biopolymer for drug delivery applications. The aim of this study was to investigate the film-coating and drug release properties of this biopolymer. Physicochemical, morphological and thermal properties of BC films were studied. Model tablets were film coated with BC, using a spray coating technique, and in vitro drug release studies of these tablets were investigated. It was found that BC exhibited excellent ability to form soft, flexible and foldable films without the addition
of any plasticizer. They were comparable to Aquacoat ECD (with plasticizer) in tensile strength, percentage elongation and elasticity modulus. Differential scanning calorimetry (DSC) BC showed a high Tg value indicating thermally stability of films. These results suggest that BC can be used as novel aqueous film-coating agent with lower cost and better film forming properties than existing film-coating agents.

Matched MeSH terms: Tablets

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