Abdel Shaheed, C, Maher, CG, Williams, KA & McLachlan, AJ 2014, 'Interventions Available Over the Counter and Advice for Acute Low Back Pain: Systematic Review and Meta-Analysis', The Journal of Pain, vol. 15, no. 1, pp. 2-15.
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Abdel Shaheed, C, Maher, CG, Williams, KA & McLachlan, AJ 2014, 'Participation of pharmacists in clinical trial recruitment for low back pain', International Journal of Clinical Pharmacy, vol. 36, no. 5, pp. 986-994.
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Clinician involvement in clinical trials research represents a significant contribution to addressing important research questions in primary care.This study aimed to explore the experiences of pharmacists recruiting patients to a low back pain (LBP) clinical trial conducted in Australia, the challenges they experienced and screening and management of people with acute LBP.This study received ethical approval (No. 13799) through the University of Sydney Human Research Ethics Committee.A convenience sample of 15 pharmacists who successfully recruited people to the clinical trial and 15 pharmacists who collaborated on the trial but did not recruit any participants were invited to complete an open ended questionnaire. The questionnaire consisted of six items framed to evaluate pharmacists' views on participation in the LBP clinical trial, ideas for addressing the challenges they experienced and screening and management of people with LBP who present to the pharmacy.A total of 30 pharmacists completed the questionnaire. Pharmacists identified lack of time and patient reluctance to participate as the major challenges to recruiting participants to the LBP clinical trial. Greater patient incentives and a more efficient paperwork system have been recommended as strategies to overcome these challenges. The recruiters and non-recruiters held similar views on pharmacological management of acute LBP and complied with guideline recommended care; although their views on the non-pharmacological management of acute LBP were less consistent with the guidelines.The experiences of pharmacists evaluated in this study has broadened the understanding around challenges to recruitment for a placebo controlled trial and identified gaps which can be addressed in future training and education of pharmacists.This study has identified time pressure as the major barrier to recruitment of participants to the LBP clinical trial. Education of pharmacists on the appropriate non-pharmacological ma...
Azzi, M, Constantino, M, Pont, L, Mcgill, M, Twigg, S & Krass, I 2014, 'Medication Safety: an audit of medication discrepancies in transferring type 2 diabetes mellitus (T2DM) patients from Australian primary care to tertiary ambulatory care', International Journal for Quality in Health Care, vol. 26, no. 4, pp. 397-403.
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Cashin, A, Stasa, H, Dunn, SV, Pont, L & Buckley, T 2014, 'Nurse practitioner prescribing practice in Australia: Confidence in aspects of medication management', International Journal of Nursing Practice, vol. 20, no. 1, pp. 1-7.
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The findings of the 2010 national survey of nurse practitioner (NP) prescribing in Australia related to confidence in prescribing are reported. A significant correlation between years endorsed as a NP and prescribing confidence was found. NPs in Australia were significantly more confident in the prescribing aspects of commencing a new medication than adjusting or ceasing a medication prescribed by others. These findings are discussed in relation to promotion of the quality use of medicines and identification of potential strategies to promote the ongoing positive evolution of NP practice in Australia.
Dolton, MJ, Perera, V, Pont, LG & McLachlan, AJ 2014, 'Terbinafine in Combination with Other Antifungal Agents for Treatment of Resistant or Refractory Mycoses: Investigating Optimal Dosing Regimens Using a Physiologically Based Pharmacokinetic Model', Antimicrobial Agents and Chemotherapy, vol. 58, no. 1, pp. 48-54.
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ABSTRACTTerbinafine is increasingly used in combination with other antifungal agents to treat resistant or refractory mycoses due to synergisticin vitroantifungal activity; high doses are commonly used, but limited data are available on systemic exposure, and no assessment of pharmacodynamic target attainment has been made. Using a physiologically based pharmacokinetic (PBPK) model for terbinafine, this study aimed to predict total and unbound terbinafine concentrations in plasma with a range of high-dose regimens and also calculate predicted pharmacodynamic parameters for terbinafine. Predicted terbinafine concentrations accumulated significantly during the first 28 days of treatment; the area under the concentration-time curve (AUC)/MIC ratios and AUC for the free, unbound fraction (fAUC)/MIC ratios increased by 54 to 62% on day 7 of treatment and by 80 to 92% on day 28 compared to day 1, depending on the dose regimen. Of the high-dose regimens investigated, 500 mg of terbinafine taken every 12 h provided the highest systemic exposure; on day 7 of treatment, the predicted AUC, maximum concentration (Cmax), and minimum concentration (Cmin) were approximately 4-fold, 1.9-fold, and 4.4-fold higher than with a standard-dose regimen of 250 mg once daily. Close agreement was seen between the concentrations predicted by the PBPK model and the observed concentrations, indicating good predictive performance. This study provides the first report of predicted terbinafine exposure in plasma with a range of high-dose regimens.
Dolton, MJ, Perera, V, Pont, LG & McLachlan, AJ 2014, 'Terbinafine in Combination with Other Antifungal Agents for Treatment of Resistant or Refractory Mycoses: Investigating Optimal Dosing Regimens Using a Physiologically Based Pharmacokinetic Model', Antimicrobial Agents and Chemotherapy, vol. 58, no. 1, pp. 48-54.
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Terbinafine is increasingly used in combination with other antifungal agents to treat resistant or refractory mycoses due to synergistic in vitro antifungal activity; high doses are commonly used, but limited data are available on systemic exposure, and no assessment of pharmacodynamic target attainment has been made. Using a physiologically based pharmacokinetic (PBPK) model for terbinafine, this study aimed to predict total and unbound terbinafine concentrations in plasma with a range of highdose regimens and also calculate predicted pharmacodynamic parameters for terbinafine. Predicted terbinafine concentrations accumulated significantly during the first 28 days of treatment; the area under the concentration-time curve (AUC)/MIC ratios and AUC for the free, unbound fraction (fAUC)/MIC ratios increased by 54 to 62% on day 7 of treatment and by 80 to 92% on day 28 compared to day 1, depending on the dose regimen. Of the high-dose regimens investigated, 500 mg of terbinafine taken every 12 h provided the highest systemic exposure; on day 7 of treatment, the predicted AUC, maximum concentration (Cmax), and minimum concentration (C min) were approximately 4-fold, 1.9-fold, and 4.4-fold higher than with a standard-dose regimen of 250 mg once daily. Close agreement was seen between the concentrations predicted by the PBPK model and the observed concentrations, indicating good predictive performance. This study provides the first report of predicted terbinafine exposure in plasma with a range of high-dose regimens. © 2014, American Society for Microbiology. All Rights Reserved.
Dua, K 2014, 'Statistical Design for Optimization and Determination of Tizanidine Hcl using Folin-Ciocalteu (Fc) as Chromogenic Reagent', Pharmaceutica Analytica Acta, vol. 05, no. 08, pp. 1-5.
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A simple, sensitive spectrophotometric method has been developed for quantitative determination of Tizanidine
Hydrochloride in bulk and pharmaceutical formulations with application of factorial design. In this method, Tizanidine
Hydrochloride is made to react with Folin-Ciocalteu (FC) reagent under alkaline conditions forming a blue chromogen
having absorption maximum at 663 nm. Beer’s law was obeyed in the concentration range of 4-36 μg/ml. Results
of the analysis were validated as per ICH guidelines and by recovery studies. A 3-factor, 3-level statistical design
(Box-Behnken) was used to derive a second-order polynomial equation to construct contour plots for prediction of
response. Independent variables studied were the FC-reagent (X1), sodium carbonate (X2) and drug concentration
(X3) and the levels of each factor were low, medium, and high. The dependent variable studied was absorbance
(Y1). The aims of this study to determination and optimize the Tizanidine HCl using FC as Chromogenic reagent; the
design demonstrated the role of the derived equation (polynomial) and two dimensional plots in predicting the values
of dependent variable for optimization.
Gupta, G, Dua, K, Kazmi, I & Anwar, F 2014, 'Anticonvulsant activity of Morusin isolated from Morus alba: Modulation of GABA receptor', Biomedicine & Aging Pathology, vol. 4, no. 1, pp. 29-32.
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Aim of the study Epilepsy is a complex neurological disorder affecting 50 million of world's total population. Number of medicinal plants has been used to treat the convulsion. In ancient time Morus alba was used to treat epilepsy and mental illness. In Chinese medicine also M. alba is used as neuroprotective herbs. The present study was designed to explore the effect of Morusin, a flavonoid glycoside isolated from M. alba as anticonvulsant activity along with biochemical mechanism. Materials and methods Morusin was isolated from M. alba and acute toxicity study was determined. Anticonvulsant activity of Morusin (5 and 10 mg/kg, i.p.) was studied by using isoniazid (INH) and maximal electroshock (MES)-induced convulsion models; diazepam (5 mg/kg) and phenytoin (20 mg/kg) were used as standards, respectively. Biochemical mechanism was investigated by estimating the GABA level in brain. Results The median lethal dose (LD ) of Morusin was found up to 20 mg/kg. Treatment with Morusin (5 and 10 mg/kg) delayed onset of convulsion and tonic hind limb extension along with duration of tonic-clonic convulsions as well as it significantly reduced mortality in INH and MES-induced convulsion. Rats treated with Morusin (5 and 10 mg/kg) significantly increased level of brain GABA at both doses. Conclusion The findings of current study provide pharmacological credibility to anticonvulsant activity of Morusin. The protection against the convulsions and restoration of GABA level give a suggestion to its probable mechanism of action. © 2013 Elsevier Masson SAS. 50
Gupta, G, Krishna, G, Chellappan, DK, Gubbiyappa, KS, Candasamy, M & Dua, K 2014, 'Protective effect of pioglitazone, a PPAR gamma agonist against acetaminophen-induced hepatotoxicity in rats', MOLECULAR AND CELLULAR BIOCHEMISTRY, vol. 393, no. 1-2, pp. 223-228.
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Acetaminophen has a reasonable safety profile when consumed in therapeutic doses. However, it could induce hepatotoxicity and even acute liver failure when taken at an overdose. Pioglitazone, PPARγ ligand, is clinically tested and used in treatment of diabetes. PPARγ is a key nuclear hormone receptor of lipid metabolisms and regulates several gene transcriptions associated with differentiation, growth arrest, and apoptosis. The aim of our study was to evaluate the hepatoprotective activity of pioglitazone on acetaminophen-induced hepatotoxicity and to understand the relationship between the PPARγ and acetaminophen-induced hepato injury. For the experiment, Sprague-Dawley rats (160-180 g) were used and divided into four groups. Groups I and II were normal and experimental controls, respectively. Groups III and IV received the pioglitazone 20 mg/kg for 10 days. Hepatotoxicity was induced in Groups II and III on the eighth day with acetaminophen (i.p. 350 mg/kg body weight). The hepatoprotective effect was evaluated by performing an assay of the total protein, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, and α-fetoprotein as well as glutathione peroxidase, lipid peroxidation, catalase, superoxide dismutase, and glutathione transferase and liver histopathology. The assay results were presented as mean and standard error of mean for each group. The study group was compared with the control group by one-way ANOVA test. A p value of <0.05 was considered significant. Pioglitazone significantly reduced the elevated level of above serum marker enzymes and also inhibits the free radical formation by scavenging hydroxyl ions. It also restored the level of LPO and significantly elevated the levels of endogenous antioxidant enzymes in acetaminophen-challenged hepatotoxicity. Liver histopathological examination showed that pioglitazone administration antagonized acetaminophen -induced liver pathological damage. Various b...
Gupta, G, Verma, R, David, SR, Chellappan, DK, Anwar, F & Dua, K 2014, 'Hepatoprotective activity of moralbosteroid, a steroidal glycoside isolated from Morus alba', Oriental Pharmacy and Experimental Medicine, vol. 14, no. 3, pp. 285-289.
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This study evaluates the hepatoprotective activity of moralbosteroid, isolated from Morus alba, against the hepatotoxicity induced by CCl4 in wistar albino rats. The level of hepatoprotection was estimated by measuring the following biochemical markers: aspartate amino-transferase (AST), alkaline phosphatase (ALP), serum alanine amino-transferase (ALT), total bilirubin (TB), and total protein (TP), including the enzymes involved in antioxidant activities like glutathione transferase (GST), glutathione peroxidase (GPx), catalase (CAT), lipid peroxidation (LPO) and superoxide dismutase (SOD). The oral administration of CCl significantly caused elevation in LPO level (13.22 ± 1.59 μM/mg protein) as compared to control. The activities of antioxidant enzymes including CAT, SOD, GPx and GST were decreased significantly (0.38 ± 0.6 nmol/min/ml, 0.89 ± 0.83 U/ml, 3.90 ± 0.91 μmol and 0.05 ± 0.16 U/min/mg protein) in testicular tissue as compared to control animals. Moralbosteroid significantly prevents the marked escalation of serum markers and inhibited the free radical processes by the scavenging of hydroxyl radicals. It also modulates the levels of LPO and prominently increases the endogenous antioxidant enzyme levels in hepatocellular toxicity induced by CCl4. The results obtained in the present study suggest the preventive influence of moralbosteroid on liver toxicity in rats induced by CCl4 comparable with those of Silymarin. © 2014 Institute of Korean Medicine, Kyung Hee University. 4
Kamal Dua, VK 2014, 'Taguchi and Quadratic via Chromogenic Design Methodology: A Better to Best Estimation Process (Tizanidine Hcl) Bulk/Pharmaceutical', Pharmaceutica Analytica Acta, vol. 05, no. 09, pp. 1-5.
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A finest quantitative responsive with reproducible best method was developed using designed array (Taguchi) and Quadratic design methodology (RSM) chromomeric spectrophotometric estimation of bulk as well as pharmaceutical (Tizanidine HCl). Initially (Taguchi), orthogonal array design was applied to find significant variables as well as optimum (better) levels. By response surface (central composite; quadratic) methodology were used to ascertain optimum to optimized “Better to Best” and studied values of variables (independent significant; X1=PDAB=chromogenic reagent; FeCl3=X2=ferric ion at optimum levels with drug constant=X3) responses (dependent Y1=absorbance) models at positive and negative (+1/-1 optimum spaces) levels. More-more, designed independent factorial levels “better to best” surface models (3D) and its polynomial (2nd order) equation was predicted the finest level which further can be considered as best chromomeric estimation method. The models analysis of experimental variables and their level showed and followed good Beer’s (5-50 μg/ml) correlation at optimized significant independent best (finest) level variables and in-addition validated using pharmaceutical guidelines (ICH; international conference on harmonization) for human use.
Madan, J, Dua, K & Khude, P 2014, 'Development and evaluation of solid lipid nanoparticles of mometasone furoate for topical delivery', International Journal of Pharmaceutical Investigation, vol. 4, no. 2, pp. 60-60.
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INTRODUCTION:Solid lipid nanoparticles (SLNs) are the new generation of submicron sized lipid emulsions where liquid lipid (oil) has been substituted by solid lipid. Lipids used in the formulation are safe, stable and biodegradable in nature. SLNs offer various advantages for topical drug delivery like ability of deposition into skin with the reduced systemic exposure and reduced local side-effects along with providing sustained release of drug. Mometasone furoate (MF) is a topical glucocorticoid having anti-inflammatory, anti-pruritic, anti-hyper proliferative activity. Owing to these properties it is recommended in chronic inflammation and psoriasis. In market, MF cream and lotion (0.1%) are available, which show slight skin irritation, burning and common side-effects due to steroids. EXPERIMENTAL:To overcome the shortcomings of conventional formulations, there is a need to develop a novel formulation that can reduce these side-effects and show maximum desired effects. Thus, SLN of MF can be prepared, which would help in increasing skin deposition as well as provide sustained release. In this study, SLNs were prepared by solvent - injection method. RESULTS:The F8 batch had shown maximum entrapment up to55.59% and sustained drug release for more than 8 h. The skin permeability of SLN loaded gel was found to be 15.21times more than that of marketed cream. SLN loaded gel showed 83.52% of skin deposition which was 2.67 times more than marketed cream and 20 times more than plain drug loaded gel. The scanning electron microscopy and zeta potential study showed formation of good SLN dispersion. The stability study showed successful formation of stable SLNs. Thus, SLNs proved the potential for topical delivery of corticosteroid drug over the conventional formulations. EXPERIMENTAL:To overcome the shortcomings of conventional formulations, there is a need to develop a novel formulation that can reduce these side-effects and show maximum desired effects. Thus, SLN of MF ...
Madan, J, Sudarshan, B, Kadam, V & Kamal, D 2014, 'Formulation and development of self-microemulsifying drug delivery system of pioglitazone hydrochloride', Asian Journal of Pharmaceutics, vol. 8, no. 1, pp. 27-27.
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Self-microemulsifying drug delivery system (SMEDDS) is a promising system for the Biopharmaceutics Classification System (BCS) class II drugs. The current research aimed to improve the dissolution of poorly water-soluble antidiabetic drug pioglitazone HCl by formulating it in SMEDDS. Liquid SMEDDS of pioglitazone HCl were formulated with Capmul MCM C8 and oleic acid as oil phase, Cremophor RH 40 and Tween 80 as surfactant phase, and Transcutol P as cosurfactant phase after screening various vehicles. The prepared formulations were evaluated for self-emulsifying ability and phase diagram was constructed to optimize the system. These systems were further characterized for globule size, effect of pH and robustness, zeta potential, drug content, viscosity, self-emulsification time, polydispersity index, % transmittance, thermodynamic stability, surface morphology, and drug release. The system was robust to different pH media and dilution volumes. The optimized system possessed a mean globule size of 122.2 nm, zeta potential around -22.9 mV, drug content 99.66 +- 0.47%, viscosity 0.8874 +- 0.026 cP, emulsification time 38 s, polydispersity index value of 0.5, and transmittance value of 99.3 +- 0.6%. Drug release in hydrochloric acid buffer pH 2 was found to be 99.35 +- 0.38%. More than three-fold increase in dissolution characteristics of pioglitazone HCl in SMEDDS was observed as compared to pure and marketed formulation. Liquid SMEDDS filled in hard gelatin capsule (HGC) shell was found to be compatible. Stability studies show there was no sign of phase separation or precipitation and no change in drug content was observed.
Moghe, R, Cheung, JMY, Saini, B, Marshall, NS & Williams, KA 2014, 'Consumers using the Internet for insomnia information: The who, what, and why', Sleep and Biological Rhythms, vol. 12, no. 4, pp. 297-304.
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Information obtained from the Internet often influences the treatment choices of patients with insomnia. This study explored patterns of online information seeking and utilization among patients with insomnia. A total of 1013 participants took part in an online survey about sleep health information between July 2012 and March 2013. Participants also completed the Insomnia Severity Index and the Dysfunctional Beliefs and Attitudes about Sleep Scale. The results showed that those seeking insomnia-related information resources frequently searched online, and the information found appeared to influence important health behaviors such as treatment decisions, taking medication and whether to seek professional care. Information of interest revolved around insomnia treatment options and symptomology. While no predictors for Internet use were identified, the Internet does represent an important health-care portal for insomnia patients and warrants further investigation as targeted e-health interventions become more prominent in the routine management of insomnia.
Pont, L, Alhawassi, T, Bajorek, B & Krass, I 2014, 'A systematic review of the prevalence and risk factors for adverse drug reactions in the elderly in the acute care setting', Clinical Interventions in Aging, vol. 9, pp. 2079-2079.
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© 2014 Alhawassi et al. Adverse drug reactions (ADRs) are an important health issue. While prevalence and risk factors associated with ADRs in the general adult population have been well documented, much less is known about ADRs in the elderly population. The aim of this study was to review the published literature to estimate the prevalence of ADRs in the elderly in the acute care setting and identify factors associated with an increased risk of an ADR in the elderly. A systematic review of studies published between 2003 and 2013 was conducted in the Cochrane Database of Systematic Reviews, EMBASE, Google Scholar and MEDLINE. Key search terms included: “adverse drug reactions”, “adverse effects”, “elderly patients and hospital admission”, “drug therapy”, “drug adverse effects”, “drug related”, “aged”, “older patients”, “geriatric”, “hospitalization”, and “emergency admissions”. For inclusion in the review, studies had to focus on ADRs in the elderly and had to include an explicit definition of what was considered an ADR and/or an explicit assessment of causality, and a clear description of the method used for ADR identification, and had to describe factors associated with an increased risk of an ADR. Fourteen hospital-based observational studies exploring ADRs in the elderly in the acute care setting were eligible for inclusion in this review. The mean prevalence of ADRs in the elderly in the studies included in this review was 11.0% (95% confidence interval [CI]: 5.1%–16.8%). The median prevalence of ADRs leading to hospitalization was 10.0% (95% CI: 7.2%–12.8%), while the prevalence of ADRs occurring during hospitalization was 11.5% (95% CI: 0%–27.7%). There was wide variation in the overall ADR prevalence, from 5.8% to 46.3%. Female sex, increased comorbid complexity, and increased number of medications were all significantly associated with an increased risk of an ADR. Retrospective studies and those relying on identification by the usual treating ...
Sharma, A, Prasad, A, Dua, K & Singh, G 2014, 'Effect of Combination of Acrylic Polymers on the Release of Nevirapine Formulated as Extended Release Matrix Pellets Using Extrusion and Spheronization Technique', Current Drug Delivery, vol. 11, no. 5, pp. 643-651.
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The aim of the present research work was to formulate and evaluate the extended release matrix pellets of nevirapine using extrusion and spheronization technique which will be an alternative technique for making extended release dosage forms and to compare the drug release profiles of the formulations with the reference product. In vitro dissolutions were carried out in 0.04M Phosphate buffer pH 6.8 with 2% w/v SLS (sodium lauryl sulphate) for 24 hours with USP type I apparatus at 75rpm. The drug release from the optimised formulation was comparable to that of the reference product and follows first order kinetics followed by non-fickian transport mechanism of drug release which confirms the drug release pattern involves complex mixture of diffusion and erosion. The similarity factor, f2 value of optimised formulation was found to be 70, which shows that the developed formulation was comparable to that of the reference product.
Swain, L, Griffits, C, Pont, L & Barclay, L 2014, 'Attitudes of pharmacists to provision of Home Medicines Review for Indigenous Australians', International Journal of Clinical Pharmacy, vol. 36, no. 6, pp. 1260-1267.
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Pont, LG, Nielen, JTHY, McLachlan, A, Gnjidic, D, Chan, L, Cumming, R & Taxis, K 1970, 'Safety of Anticholinergic Medications in the Elderly: Anticholinergic Burden and Lower Urinary Tract Symptoms (LUTS)', PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, WILEY-BLACKWELL, pp. 191-191.
Roughead, L, Haaijer-Ruskamp, F, Wirtz, V, Gurumurthy, P & Pont, LG 1970, 'Using Pharmaceutical Data for Evaluating Medicines Policy and Informing Quality Use of Medicines', PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, WILEY-BLACKWELL, pp. 365-365.
Starkey, M, Hanish, I, Dua, K, Nair, P, Haw, T, Hsu, A, Foster, P, Knight, D, Horvat, J, Wark, P & Hansbro, P 1970, '175', Cytokine, 2nd Annual Meeting of the International-Cytokine-and-Interferon-Society (ICIS), Elsevier BV, Melbourne, AUSTRALIA, pp. 70-70.
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Taxis, K, Kochen, S, Geerens, S, Wouters, H, Boersma, F, Maring, JG, Mulder, H, Pavlovic, J, Stevens, G, McLachlan, AJ & Pont, L 1970, 'Cross-National Comparison of Prescribing Patterns in Australian and Dutch Nursing Homes', PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, WILEY-BLACKWELL, pp. 173-173.
