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   2013| July-September  | Volume 4 | Issue 3  
    Online since August 21, 2013

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Informed consent: Issues and challenges
Lokesh P Nijhawan, Manthan D Janodia, BS Muddukrishna, KM Bhat, KL Bairy, N Udupa, Prashant B Musmade
July-September 2013, 4(3):134-140
DOI:10.4103/2231-4040.116779  PMID:24083200
Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.
  39,428 7,359 98
Formulation and optimization of fast dissolving intraoral drug delivery system for clobazam using response surface methodology
Rajni Bala, Sushil Khanna, Pravin K Pawar
July-September 2013, 4(3):151-159
DOI:10.4103/2231-4040.116785  PMID:24083203
Clobazam is a newer 1,5-benzodiazepine used for the treatment of epilepsy. It is better tolerated and less sedating than other benzodiazepines. Absorption of the drug can be impacted by oral fast dissolving dosage form; this may have implications for epilepsy in pediatrics and those having difficulty in swallowing tablets/capsules resulting in improved patient compliance. The purpose of the present investigation was to formulate and optimize clobazam oro-dissolving tablets by direct compression method using response surface methodology (RSM). Oro-dispersible tablets of clobazam were prepared by direct compression method using crospovidone (2-6%) as a superdisintegrant, microcrystalline cellulose (MCC) (20-40%) was used as diluents along with directly compressible mannitol to enhance mouth feel. A 3 2 full factorial design was applied to investigate the combined effect of two formulation variables: amount of crospovidone and MCC over the independent variables disintegration time, wetting time and percent drug release. Disintegration time showed by all formulations was found to be in the range of 24.3-193 s based on evaluation parameters the formulation containing 6% of crospovidone and 30% of MCC showed promising performance against all other formulations. The results demonstrated that the RSM could efficiently be applied for the formulation of clobazam oro-dispersible tablets; therefore, constitute an advance in the management of epileptic attacks.
  5,801 712 8
A comparative study of efficacy of atorvastatin alone and its combination with fenofibrate on lipid profile in type 2 diabetes mellitus patients with hyperlipidemia
Meenakshi Lella, K Indira
July-September 2013, 4(3):166-170
DOI:10.4103/2231-4040.116778  PMID:24083205
Mixed dyslipidemia is characterized by increased low-density lipoprotein cholesterol (LDL-C) elevated triglycerides (TGs) and decrease high-density lipoprotein cholesterol (HDL-C). It is more common in diabetes and is associated with an increased risk of coronary artery disease. Monotherapy with statins or fibrates may not effectively control all lipid parameters. The atorvastatin-fenofibrate combination has been shown to have highly beneficial effect on lipid parameters in type 2 diabetes associated with combined hyperlipidemia (CHL). In an open-label study, we evaluated the efficacy of atorvastatin alone and in combination with fenofibrate in 60 types 2 diabetes mellitus patients associated with hyperlipidemia. Patients were randomly assigned to receive atorvastatin 10 mg (Group 1) or combination of atorvastatin 10 mg and fenofibrate 145 mg (Group 2) once daily for 12 weeks. The effect of drugs on lipid profile was evaluated before and after treatment. After 12 weeks, the reduction in total cholesterol (TC), TGs, LDL-C, VLDL-C was 28%, 20%, 37% and 20% in Group 1 (P < 0.001 for all) as compared with 31%, 39%, 33% and 40% in Group 2 (P < 0.001 for all). There was insignificant rise in HDL-C in Group 1 (P = 0.71) and insignificant decrease in HDL-C (P = 0.70) in Group 2. During the combination therapy, the decrease in TC, TGs and VLDL-C was greater than atorvastatin alone. The combination of atorvastatin with fenofibrate in type 2 diabetes patients with CHL may have a favorable effect on some major coronary artery disease risk factors.
  4,618 654 5
Method development for Lawsone estimation in Trichup herbal hair powder by high-performance thin layer chromatography
Maunang M Patel, Bhavna R Solanki, Nilesh C Gurav, Prateek H Patel, Shweta S Verma
July-September 2013, 4(3):160-165
DOI:10.4103/2231-4040.116780  PMID:24083204
A simple, specific, accurate, precise and robust high-performance thin-layer chromatographic method has been developed and validated for estimation of Lawsone in Trichup herbal hair powder (coded as a THHP), polyherbal formulation. The chromatographic development was carried out on aluminum plates pre-coated with silica gel 60F 254 and good resolution was achieved with Toluene: Ethyl acetate: Glacial acetic acid (8:1:1 v/v/v) as mobile phase. Lawsone detection was carried out densitometrically at 277 nm and obtained retardation factor value was 0.46 ± 0.02. The method was validated with respect to specificity, linearity, accuracy, precision and robustness. The calibration curve was achieved to be linear over a range of 5-60 μg/ml and regression coefficient was obtained 0.998. Accuracy of chromatographic method was evaluated by standard addition method; recovery was obtained 99.25 ± 0.61% . The peak purity of Lawsone was achieved 0.999 r. Relative standard deviation for intraday and inter-day precision was 0.37-0.56% and 0.42-0.55%, respectively. The limit of detection and limit of quantification of the Lawsone were found to be 1.08 μg/m land 3.28 μg/ml, respectively. This result shows that the method was well validated. In the present study, the Lawsone content was found 0.322 ± 0.014% in THHP. This study reveals that the proposed high performance thin layer chromatography method is accurate, fast and cost- effective for routine estimation of Lawsone in polyherbal formulation.
  4,688 561 4
β-sitosterol in different parts of Saraca asoca and herbal drug ashokarista: Quali-quantitative analysis by liquid chromatography-mass spectrometry
Anjum Gahlaut, Amey Shirolkar, Vikas Hooda, Rajesh Dabur
July-September 2013, 4(3):146-150
DOI:10.4103/2231-4040.116783  PMID:24083202
β-sitosterol is an important component in food and herbal products and beneficial in hyperlipidemia. Its higher concentrations in serum may lead to coronary artery disease in case of sitosterolemia. Therefore, it is essential to determine the quantity of β-sitosterol in food and herbal drugs. Saraca asoca and its preparations have been widely used by traditional healers are also a source of β-sitosterol. In the present study, quantitative estimation of β-sitosterol present in hot and cold water extracts of bark, regenerated bark, leaves and flowers of the S. asoca and Ashokarista drugs were carried out first time using high performance liquid chromatography coupled (HPLC) with quadrupole time-of-flight mass spectrometry. Different concentrations of β-sitosterol and crude extracts were estimated by HPLC and targeted mass spectrometry. Standard curve for β-sitosterol was prepared from the intensities of transitions (397.50 → 147.0987 m/z) having regression coefficient (r 2) 0.9952. Out of eight extracts and two drugs used in the study bark water, leaves water and leaves hot water extracts were found to have a considerable quantity of β-sitosterol, i.e. 170, 123.5 and 19.3 ng/mL, respectively. The results showed significant differences in the distribution of β-sitosterol among different organs of S. asoca and drugs prepared from its bark. HPLC/electrospray ionizationmass spectroscopy method is accurate, reproducible and requires less specimen, sample preparation and analysis time over HPLC assay. This type of approaches could be helpful for the quality control of herbal medicines and provides necessary information for the rational utilization of plant resources.
  4,526 604 4
Clinical Research in India: The current scenario and prospects
Bhaswat S Chakraborty
July-September 2013, 4(3):126-127
DOI:10.4103/2231-4040.116776  PMID:24083198
  4,166 574 2
Rheological behavior and stability of ciprofloxacin suspension: Impact of structural vehicles and flocculating agent
Eskandar Moghimipour, Saeed Rezaee, Anayatollah Salimi, Elham Asadi, Somayeh Handali
July-September 2013, 4(3):141-145
DOI:10.4103/2231-4040.116781  PMID:24083201
Ciprofloxacin is a fluoroquinolone and is used against a broad spectrum of gram-negative and gram-positive bacteria. The aim of the study is to investigate the effect of structural vehicles and other formulating factors on physical stability and rheological behavior of ciprofloxacin suspension. To formulate the suspensions, the effect of glycerin and polysorbate 80 as wetting agents was evaluated. Then to achieve controlled flocculation, different concentrations of sodium chloride and calcium chloride were added. After choosing suitable wetting and flocculating agents, structural vehicles such as sodium carboxyl methyl cellulose (NaCMC), hydroxypropylmethylcellulose (HPMC) and Veegum were evaluated. Physical stability parameters such as sedimentation volume, the degree of flocculation and the ease of redispersion of the suspensions and growth of crystals were evaluated. After incorporation of structural vehicles, the rheological properties of formulations containing were also studied to find out their rheological behavior. According to the results, suspension containing glycerin (0.2% w/v) and sodium chloride (0.05% w/v) as wetting agent and flocculating agent, respectively, were the most stable formulations regarding their F and N. Microscopic observations showed the growth of crystals in ciprofloxacin suspension in formulation without excipients and the minimum amount of crystal growth was seen in suspension containing NaCMC (0.25% w/v), Veegum (0.1% w/v) and NaCl (0.05% w/v). Rheological studies showed that almost all of the formulations had psuedoplastic behavior with different degree of thixotropy. The formulation containing NaCMC (0.25% w/v), Veegum (0.1% w/v) and NaCl (0.05% w/v) was the most stable formulation. It may be concluded that by altering the amount ratios of formulation factors, the best rheological behavior and the most proper thixotropy may be achieved.
  3,977 549 2
Assessment of multifunctional contrast agent probes in neuroimaging: Implications of nanopharmaceutical therapeutic interventions
Lina H Machtoub
July-September 2013, 4(3):128-133
DOI:10.4103/2231-4040.116777  PMID:24083199
Recently, a clear association has been found between the progression of motor neurodegenerative disorders (MNDs) and carotid atherosclerosis. Significant vascular abnormalities with arterial hypertension were shown to be in patients with familial antecedents of MNDs. The main scope of this work is to explore the feasibility of recently developed integrated nano-based imaging modalities for the assessment of early diagnosis of the inflammatory processes associated with the neurological disorder syndromes, with the implication of recently developed nanopharmaceutical therapeutic interventions.
  3,134 289 1
Society of Pharmaceutical Education and Research™ official news magazine "SPER Times" inaugural issue released
Upendra Nagaich
July-September 2013, 4(3):125-125
DOI:10.4103/2231-4040.116774  PMID:24083197
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