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   Table of Contents - Current issue
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April-June 2017
Volume 7 | Issue 2
Page Nos. 41-110

Online since Monday, July 24, 2017

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REVIEW ARTICLES  

Compensation to clinical trial participants in India: A gap analysis p. 41
Mohd Urooj, Gulam Mohammed Husain, Mohammad Ahmed Khan, Munawwar Husain Kazmi
DOI:10.4103/jphi.JPHI_31_17  
The recent amendments notified by the Government of India, for conducting clinical trial, is greatly appreciable as promoting safety and well-being of human subjects. These rules clearly state that medical management of injuries in clinical trials is mandatory, and clinical trial-related injury or death needs to be compensated over and above the medical management. These rules need to be reconsidered for simplification and better understanding of issues regarding compensation. There is a need of clarity at some points which should be discussed with all stakeholders for better understanding of current regulations. In our view, attention must also be given to academic investigators, during discussion to promote availability of cost-effective treatment in India.
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Application of three-dimensional printing for colon targeted drug delivery systems p. 47
Nitin B Charbe, Paul A McCarron, Majella E Lane, Murtaza M Tambuwala
DOI:10.4103/jphi.JPHI_32_17  
Orally administered solid dosage forms currently dominate over all other dosage forms and routes of administrations. However, human gastrointestinal tract (GIT) poses a number of obstacles to delivery of the drugs to the site of interest and absorption in the GIT. Pharmaceutical scientists worldwide have been interested in colon drug delivery for several decades, not only for the delivery of the drugs for the treatment of colonic diseases such as ulcerative colitis and colon cancer but also for delivery of therapeutic proteins and peptides for systemic absorption. Despite extensive research in the area of colon targeted drug delivery, we have not been able to come up with an effective way of delivering drugs to the colon. The current tablets designed for colon drug release depend on either pH-dependent or time-delayed release formulations. During ulcerative colitis the gastric transit time and colon pH-levels is constantly changing depending on whether the patient is having a relapse or under remission. Hence, the current drug delivery system to the colon is based on one-size-fits-all. Fails to effectively deliver the drugs locally to the colon for colonic diseases and delivery of therapeutic proteins and peptides for systemic absorption from the colon. Hence, to overcome the current issues associated with colon drug delivery, we need to provide the patients with personalized tablets which are specifically designed to match the individual's gastric transit time depending on the disease state. Three-dimensional (3D) printing (3DP) technology is getting cheaper by the day and bespoke manufacturing of 3D-printed tablets could provide the solutions in the form of personalized colon drug delivery system. This review provides a bird's eye view of applications and current advances in pharmaceutical 3DP with emphasis on the development of colon targeted drug delivery systems.
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ORIGINAL RESEARCH ARTICLES Top

Determining frequency of genes of CTX-M and CTX-M-15 of producing Enterobacteriaceae of isolated extended-spectrum beta-lactamases from clinical samples of patients referred to training hospitals of Medical Sciences University, Khorramabad, Iran p. 60
Seyed Mojtaba Mosavian, Azam Rezvani-Rad
DOI:10.4103/jphi.JPHI_4_17  
Objective: The purpose of conducting this research was evaluation of the frequency of extended-spectrum beta-lactamases (ESBLs) in separated Enterobacteriaceae isolates from clinical samples in Khorramabad city and determination of their antimicrobial resistance pattern. Materials and Methods: In this study, 240 isolates belonging to Enterobacteriaceae family were collected in time duration between March and June in 2014. The isolates were identified by standard biochemical tests. Producing isolates of enzymes of ESBLs were identified by combined disc method and based on the Clinical and Laboratory Standards Institute criterion, and then, frequency of genes of blaCTX-M and blaCTX-M-15 in positive phenotypic isolates was determined using polymerase chain reaction method. Results: In the present research, the most frequency was, respectively, belonged to Escherichia coli with 76%, Klebsiella pneumoniae - 16.2%, Citrobacter freundii - 5.4%, Proteus mirabilis - 1.6%, and Enterobacter - 0.83%. The obtained results from determining the antibiotic sensitivity pattern in the separated isolates showed that the maximum resistance of different isolates was related to antibiotics of ampicillin 88% while the minimum antibiotic resistance of isolates was related to the amikacin antibiotic with resistance value of 2.5%. The obtained results from the combined disc phenotypic method in the present research showed that from 240 Enterobacteriaceae isolates, 59% was generators of ESBLs. In addition, 85% of positive phenotype Enterobacteriacea had genes of blaCTX-M-15 and blaCTX-M that totally formed 50.4% of all separated bacteria from the clinical samples. Conclusion: The obtained results from the present research showed that the prevalence of ESBL enzymes and antibiotic resistance to ESBLs is high among the separated Enterobacteriaceae isolates from the clinical samples in Khorramabad city. Hence, policies of prescription of antibiotics and infection control in hospitals should be reviewed.
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Brand versus generic dispensing trend for ciprofloxacin 500 mg, levofloxacin 500 mg, and moxifloxacin 400 mg (oral dosage forms) among pharmacies of Karachi, Pakistan p. 70
Fatima Zehra, Atta Abbas Naqvi, Sumbul Tasneem, Rizwan Ahmad, Niyaz Ahmad, Adnan Zia Shamsi, Naqiya Ali Asghar, Ghufran Ullah Khan
DOI:10.4103/jphi.JPHI_15_17  
Introduction: Pakistan spends 0.7% of its gross domestic product on health. The public sector health-care system provides services to 22% of population thus paving the way for a dominant private sector. Patients in Pakistan mostly pay their medical expenses directly, and 64% of the health expenditures are borne by the household. Expenditure on medicine constitutes 43% of the total household expenditure. Methods: A quantitative cross-sectional study was conducted in Karachi, Pakistan, for a month. It was aimed at gathering response from different pharmacies to understand the brand versus generic dispensing trend of ciprofloxacin 500 mg, levofloxacin 500 mg, and moxifloxacin 400 mg oral dosage forms. The study employed convenience sampling and used a survey checklist. The data gathered was entered in SPSS version 22. Results: The mean price per tablet for ciprofloxacin brand and generic was reported at Pakistani Rupees (PKR) 48.44 and PKR 26.85, respectively. The trend for dispensing ciprofloxacin highlighted a split in the market between brand (51%) and generic (49%). For levofloxacin brand and generic, the price per tablet was reported at PKR 36.50 and PKR 36.15 respectively, and despite same price, the market was dominated by generic levofloxacin (92%). Due to a price difference between brand and generic moxifloxacin, i.e., PKR 129.44 and PKR 71.91, respectively, the market was mostly occupied by the generic form (75%). Conclusion: Pricing mechanism must be revisited, and the authorities should take stern actions against any illegitimate price hike. The surging burden of drug expenditure on poorer sections of the society must be addressed by the government on an urgent basis.
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Antifungal effects of Lactobacillus species isolated from local dairy products p. 77
Sahar Karami, Mohammad Roayaei, Elnaz Zahedi, Mahmoud Bahmani, Leila Mahmoodnia, Hosna Hamzavi, Mahmoud Rafieian-Kopaei
DOI:10.4103/jphi.JPHI_9_17  
Objective: The Lactobacillus is a genus of lactic acid bacteria which are regularly rod-shaped, nonspore, Gram-positive, heterogeneous, and are found in a wide range of inhabitants such as dairy products, plants, and gastrointestinal tract. A variety of antimicrobial compounds and molecules such as bacteriocin are produced by these useful bacteria to inhibit the growth of pathogenic microbes in the food products. This paper aims to examine the isolation of Lactobacillus from local dairies as well as to determine their inhibition effect against a number of pathogens, such as two fungi: Penicillium notatum and Aspergillus fulvous. Materials and Methods: Twelve Lactobacillus isolates from several local dairies. After initial dilution (10−1–10−3) and culture on the setting, de Man, Rogosa and Sharpe-agar, the isolates were recognized and separated by phenotypic characteristics and biochemical; then their antifungal effect was examined by two methods. Results: Having separated eight Lactobacillus isolates, about 70% of the isolates have shown the inhabiting areas of antifungus on the agar-based setting, but two species Lactobacillus alimentarius and Lactobacillus delbrueckii have indicated a significant antifungal effect against P. notatum and A. fulvous. Except bacteriocin, lactic acid, and acetic acid, the inhibitor substance is produced by these bacteria. Conclusion: Given the vitality of Lactobacillus in human health, recognition and isolation of the species producing compound in antagonist to the pathogens existing in the food products can be a helpful and effective step toward maintaining the valuable native Lactobacillus and using them in the dairy industries.
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Synergistic effect of Carum copticum and Mentha piperita essential oils with ciprofloxacin, vancomycin, and gentamicin on Gram-negative and Gram-positive bacteria p. 82
Gholam-Reza Talei, Mohsen Mohammadi, Mahmoud Bahmani, Mahmoud Rafieian Kopaei
DOI:10.4103/jphi.JPHI_12_17  
Background: Infectious diseases have always been an important health issue in human communities. In the recent years, much research has been conducted on antimicrobial effects of nature-based compounds because of increased prevalence of antibiotic resistance. The present study was conducted to investigate synergistic effect of Carum copticum and Mentha piperita essential oils with ciprofloxacin, vancomycin, and gentamicin on Gram-negative and Gram-positive bacteria. Materials and Methods: In this experimental study, the synergistic effects of C. copticum and M. piperita essential oils with antibiotics on Staphylococcus aureus (ATCC 25923), Enterococcus faecalis (ATCC 29212), Escherichia coli (ATCC 8739), Pseudomonas aeruginosa (ATCC 9027), Staphylococcus epidermidis (ATCC 14990), and Listeria monocytogenes (ATCC 7644) were studied according to broth microdilution and the MIC and fractional inhibitory concentration (FIC) of these two essential oils determined. Results: C. copticum essential oil at 30 μg/ml could inhibit S. aureus, and in combination with vancomycin, decreased MIC from 0.5 to 0.12 μg/ml. Moreover, the FIC was derived 0.24 μg/ml which represents a potent synergistic effect with vancomycin against S. aureus growth. C. copticum essential oil alone or combined with other antibiotics is effective in treating bacterial infections. Conclusions: In addition, C. copticum essential oil can strengthen the activities of certain antibiotics, which makes it possible to use this essential oil, especially in drug resistance or to lower dosage or toxicity of the drugs.
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Comparison of effectiveness of Calendula officinalis extract gel with lycopene gel for treatment of tobacco-induced homogeneous leukoplakia: A randomized clinical trial p. 88
Manisha Singh, Anjana Bagewadi
DOI:10.4103/jphi.JPHI_19_17  
Aim: The aim of the study is to assess the efficacy of Calendula officinalis gel as cost-effective treatment modality in comparison to lycopene gel in the treatment of leukoplakia. Materials and Methods: The study comprised of sixty patients of clinically diagnosed and histopathologically confirmed cases of homogeneous leukoplakia which were divided into Group I and Group II with thirty patients each. Group I patients were dispensed C. officinalis extract gel whereas Group II patients were given lycopene gel. The therapy was instituted for 1 month to assess the change in the size of the lesion at the baseline and posttreatment. Results: The results revealed a statistically significant difference in both Group I and Group II when the pre- and post-treatment results were compared in the same group. The mean difference in the reduction in size before and after treatment for Group I was 2.0% ±1.0 cm while for the Group II, it was 1.57% ±0.87 cm. The intergroup comparison for the evaluation of reduction in the size of the lesion did not reveal statistically significant results. Conclusion: C. officinalis extract gel can be effectively used as an alternative to conventional treatment modality.
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Simultaneous determination of rutin, isoquercetin, and quercetin flavonoids in Nelumbo nucifera by high-performance liquid chromatography method p. 94
P Naveen, HB Lingaraju, Anitha , K Shyam Prasad
DOI:10.4103/jphi.JPHI_33_17  
Objective: The present study was investigated to provide a documentary evidence for the determination of rutin, isoquercetin, and quercetin flavonoids from the flora of Nelumbo nucifera by reversed-phase high-performance liquid chromatography (RP-HPLC). Materials and Methods: RP-HPLC analysis was performed by gradient elution with a low-pressure gradient using 0.5% acetic acid: acetonitrile as a mobile phase with a flow rate of 1.0 ml/min. The separation was done at 26°C using a Kinetex XB-C18 column as stationary phase and the detection wavelength at 356 nm. The proposed method was validated as per International Conference on Harmonisation guidelines with respect to specificity, linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). Results: The validated results were within the acceptable limits. In specificity, the retention time of rutin, isoquercetin, and quercetin peak in the sample was matched with the reference standard peak and showed good resolution. An excellent linearity was obtained with correlation coefficient (r) higher than 0.999. In precision, the repeatability and intermediate showed <1.0% of % relative standard deviation of peak area percentage indicating high precision and accurate. The recovery rate for rutin, isoquercetin, and quercetin was between 99.85%–101.37%, 101.90%–103.24%, and 101.74%–106.73%, respectively. The lower LOD and LOQ of rutin, isoquercetin, and quercetin enable the detection and quantitation of these flavonoids in N. nucifera at low concentrations. Conclusion: The developed analytical method is convenient for the determination of flavonoids content in herbal drugs.
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Thermoreversible in situ gel for subgingival delivery of simvastatin for treatment of periodontal disease p. 101
Swaminathan Rajendran, K Sathesh Kumar, S Ramesh, Suresh Ranga Rao
DOI:10.4103/jphi.JPHI_26_17  
Objective: The aim of this in vitro study was to formulate an in situ thermoreversible injectable gel with poloxamer (PM) and methylcellulose (MC) to deliver simvastatin (SMV) in a controlled manner. Subjects and Methods: Preformulation studies (Fourier transform infrared and differential scanning calorimetry) to assess the interaction between SMV and MC and PM were performed before gel formulation. Keeping the concentration of SMV at 2.2%, the concentration of PM and MC was altered to formulate in situ thermosensitive gel at 37°C. Rheological studies were carried to analyze the physical property of the various formulations. Drug release profile and stability studies were done for the selected formulation. The in vitro drug release profile was carried out for using open end tube method and ultraviolet spectroscopy. Results: The preformulation studies showed that there is no interaction between the polymer and drug based on the rheological studies of different formulation, the formulation. F8 gels at 37°C and attains a viscosity of 4150 cps. Conclusions: PM 25% and MC 5% formed an ideal thermosensitive injectable gel at 37°C for subgingival delivery of SMV and also show controlled drug release for the period of 10 days in vitro.
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CASE REPORT Top

Prosthetic rehabilitation of a geriatric patient with squamous cell carcinoma of the buccal mucosa: A report of clinical challenges p. 107
Raghavendra Adaki, Sarvesh Raikar, Kamal Shigli, Sivaranjani Gali
DOI:10.4103/jphi.JPHI_17_17  
Objective: This article aims to highlight the rehabilitation of a geriatric patient with an orofacial cheek defect by an extraoral silicone prosthesis. Methodology: Structured extra- and intra-oral examination of tissues coupled with a justified choice of impression materials, techniques, and prosthetic rehabilitation with a high-temperature vulcanizing silicone was done. Results: The presence of compressible tissues, static appearance of the prosthesis during patient's facial movements, variability in complexion of the skin around the defect, and manipulating heat-vulcanized silicone were the challenges faced during clinical procedures. Rehabilitation of orofacial defects is a challenge to the maxillofacial prosthodontist due to limited material properties, soft-tissue mobility, compromised retention of prostheses, and poor patient acceptance. The fabrication of a facial prosthesis is as much an art as it is science. Prosthetic form, coloration, and texture of the prosthesis must be indiscernible from the surrounding tissues. Prosthetic reconstruction helps in restoring functional disability and aids in raising the morale of the patient. Prosthetic options of rehabilitation include interim and definitive conventional adhesive-retained or implant-retained prostheses. Initially, vulcanite rubber and acrylic resins were used for reconstruction. Conclusion: We report clinical challenges during extraoral rehabilitation of orofacial tissues with a silicone cheek prosthesis such as impression making and shade matching during restoration in a geriatric patient. The use of silicone maxillofacial elastomers allowed intrinsic, extrinsic coloring and ease of construction.
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