Open Access Original Research Article

Rationality and Ethics of Promotional Drug Literature in Medical Journals

Rajendra Sharma, D. C. Dhasmana, Taruna Sharma

Journal of Pharmaceutical Research International, Page 1-6
DOI: 10.9734/BJPR/2016/23190

Introduction: Currently irrational prescribing is a major concern to community physicians. The promotional drug literature of pharmaceutical companies in medical journal is an important mode to get the information about new drug being introduced and marketed in the country. Most of the community physician depends completely on these published dug literatures. That’s why it is important to maintain high standards of quality of drug advertisement published in medical journals and thus help physician prescribe drugs in a rational manner.

Aims and Objective: To evaluate and compare the quality of drug promotional advertisement published in an Indian and international medical journal and highlight the measures to improve the quality of drug advertisement.

Materials and Methods: It was an observational cross sectional study of promotional drug advertisements published in two medical journals i.e. one Indian and one international journal over a period of one year [June-2014 to June-2015]. Advertisements pertaining to parenteral fluids, milk foods, medical devices, laboratory equipment and the educational advertisements were excluded. The identified published drug advertisements were evaluated for adherence to the ethical guidelines of World Health Organization (WHO) or the Organisation of Pharmaceutical Producers of India (OPPI).

Results: A total of 76 and 35 medicinal drug advertisements were published in an Indian and an international medical journal respectively. There was a significant difference in compliance to WHO criteria among Indian (43.5±35.2) and international (70.6±23.8) journal [p< 0.05]. Only brand name and manufacturer details were provided in all the promotional drug literature i.e. 100% compliance. There was significant difference in the compliance to WHO criteria for active ingredient causing adverse reaction, pregnancy category, precaution and contraindication, drug interaction, dosage regimen and date of production in the two journals.

Conclusion: The compliance criteria are frequently overlooked by the medical journal publishers. It is expected that the promotional drug literature may be thoroughly checked for compliance more so by the reputed Indian than an international medical journal.

Open Access Original Research Article

Phenolic Contents and In vitro Pharmacological Activities of Methanolic Extract of Pterocarpus erinaceus Poir. Stem Bark (Fabaceae)

Ouédraogo Noufou, W. R. Sawadogo, A. Tibiri, M. Lompo, M. G. Dijoux, M. Diederich, I. P. Guissou

Journal of Pharmaceutical Research International, Page 1-7
DOI: 10.9734/BJPR/2016/23149

Aim: To investigate the cytotoxic effect of methanol extract of Ptreocarpus erinaceus stem barks against cancer lines (Leukemia cell K562 and lung small cells A549) and its inhibition effects against NF-кB activation and lipoxygenase enzyme. Moreover, phenolic compounds, tannins and flavonoids amounts have been determined.

Study Design: In vitro evaluation of cytotoxic activity, inhibitor effect against NF-кB activation and lipoxygenase; and quantitative determination of total phenolic contents.

Place and Duration of Study: Laboratory of Département de médecine-pharmacopée traditionnelle and Laboratoire of Biologie Moléculaire et Cellulaire du Cancer (February – November 2013).

Methodology: The cytotoxicity of methanol extract from stem bark of this plant against cancer cell lines (Leukemia cell K562 and lung small cells A549), and its inhibition of NF-кB activation in K562 cells and lipoxygenase were studied. Additionally phytochemical composition including phenolic, tannins, flavonoids and flavonols was determined by using standard methods.

Results: At 50 µg/mL, the methanol extract of P. erinaceus inhibited the growth of K562 and A549 cells with inhibition percentage of 46.2±4.0 and 59.4±4.5% respectively. Extract inhibited NF-кB activation at 50 µg/mL (86.5±2.7%), and lipoxygenase activity was significantly inhibited by extract at 100 µg/mL (97.7±0.5%). Phytochemical analysis shows the presence of phenolic compounds, tannins, flavonoids and flavonols in a methanolic extract of Pterocarpus erinaceus stem bark.

Conclusion: Pterocarpus erinaceus stem bark showed significant cytotoxic effect and inhibited NF-кB activation and lipoxygenase. These pharmacological effects could be due to the presence of phenolic compounds, tannins, flavonoids and flavonols.

Open Access Original Research Article

Preparation and in-vitro Evaluation of Ranitidine Mucoadhesive Microspheres for Prolonged Gastric Retention

K. Vijayabhaskar, Kambham Venkateswarlu, S. B. Thirumalesh Naik, R. Kiran Jyothi, G. Nethra Vani, K. B. Chandrasekhar

Journal of Pharmaceutical Research International, Page 1-12
DOI: 10.9734/BJPR/2016/22670

Aim: The purpose of this study was to prepare and characterize mucoadhesive microspheres of Ranitidine (RNT) for prolonged gastric retention.

Materials and Methods: Mucoadhesive microspheres were prepared by ionic gelation method using the polymer Sodium alginate (SA) along with various copolymers like Sodium Carboxy Methyl Cellulose (SCMC), Hydroxy Propyl Methyl Cellulose K100 (HPMC K100), Carbopol 934P (Car 934P), Eudargit RS100 (Eud RS100) and characterized by the parameters like particle size, micromeritic properties, drug entrapment efficiency, swelling index, mucoadhesion capacity and in-vitro drug release.

Results: FTIR studies confirmed that there was no chemical interaction between the drug and polymers. The flow properties were found to be excellent and in-vitro drug release study was performed in pH 1.2 HCl buffer for 24 h time duration. From the in-vitro release studies, formulations F1, F5 and F8 showed optimum drug release, thereby optimized for further study.

Conclusion: Kinetic studies proved that the drug release from the microspheres followed zero order kinetics and mechanism was found to be diffusion, particularly non-fickian or anomalous transport. Relatively formulation F1 showed better results than the F5 & F8 formulations.

Open Access Original Research Article

Cytotoxic and Apoptotic Effects of the Bark of Two Common Mango (Mangifera indica) Varieties from Sri Lanka on Breast and Ovarian Cancer Cells

Meran Keshawa Ediriweera, Kamani Hemamala Tennekoon, Sameera Ranganath Samarakoon, Ira Thabrew, E. Dilip de Silva

Journal of Pharmaceutical Research International, Page 1-7
DOI: 10.9734/BJPR/2016/24004

Aims: The present study was planned to evaluate cytotoxic and apoptotic properties of the bark of two common mango varieties (Mangifera indica L.) grown in Sri Lanka [Rata Amba (RA) and Karthakolomban (KA)] in MCF-7 (ER positive breast cancer), MDA-MB-231 (triple negative breast cancer), SKOV-3 (ovarian epithelial cancer) cancer cell lines and normal mammary epithelial cells (MCF-10A).

Place and Duration of the Study: At the Institute of Biochemistry, Molecular Biology and Biotechnology, University of Colombo between 1st of February 2015 to April 2015.

Methodology: Cancer cells and normal cells were treated with organic extracts (hexane, chloroform, ethyl acetate and methanol) of RA and KA bark and cytotoxic effects were evaluated by SRB assay. Free radical scavenging ability on 1,1-diphenyl-2-picrylhydrazyl (DPPH) was also tested for active extracts. Furthermore, apoptotic effects of cytotoxic extracts were analysed by caspase 3 and 7 activation, DNA fragmentation, acridine orange/ethidium bromide (AO/EB) and Hoechst staining.

Results: Of the four solvent extracts used, only the methanol extract showed anti-proliferative effects against all three cancer cell lines in a dose-dependent manner. Cytotoxicity of the methanol extract of RA was higher (MCF-7 IC50- 81.1 µg/mL, MDA-MB-231 IC50- 91. 5 µg/mL and SKOV-3 IC50- 71.5 µg/mL) compared to that of the methanol extract of KA (MCF-7 IC50- 123.9 µg/mL, MDA-MB-231 IC50- 111.2 µg/mL and SKOV-3 IC50- 137.2 µg/mL). Both the methanol extracts showed less cytotoxicity to normal mammary epithelial cells [IC50- 255.6 µg/mL (RA) and IC50- 615.6 µg/mL (KA)]. Methanol extracts also exhibited strong free radical scavenging ability on 1,1-diphenyl-2-picrylhydrazyl (DPPH). Furthermore, methanol extract showed apoptotic effect against all tested cancer cell lines.

Conclusion: Overall findings of this study suggest that methanol extracts of the bark of two common mango varieties tested exhibit cytotoxicity through induction of apoptosis through caspase dependent mechanisms.

Open Access Original Research Article

Proximate, Mineral and Anti-nutrient Contents in Psophocarpus tetragonolobus (L) DC. (Winged Bean) Leaves

J. A. Alalade, J. A. Akinlade, O. A. Aderinola, A. N. Fajemisin, T. O. Muraina, T. A. Amoo

Journal of Pharmaceutical Research International, Page 1-7
DOI: 10.9734/BJPR/2016/22087

The leaves of Psophocarpus tetragonolobus (L) DC. (Winged bean) was evaluated for the proximate, mineral and anti-nutritional composition. Atomic absorption spectrometry was used in determination of the leaves for Phosphorus, Potassium, Magnesium, Calcium, Iron and Zinc. Anti-nutritional factors (ANFs) including tannin, oxalate and phytate were also determined using appropriate technique. The results of proximate analysis indicate that the leaves had high crude protein (26.29%), moisture (75.29%), dry matter (24.71%), ether extract (4.10%), crude fibre (10.04%), and ash (5.08%). Mineral analysis indicate the Psophocarpus tetragonolobus leaves contained some essential mineral such as K+ (0.84%), Ca2+ (0.30%), P (0.34%), Mg (0.40%), Fe2+ (181.66 mg/kg) and Zn (61.27 mg/kg). The leaves of P. tetragonolobus have low concentration of ant- nutritive factor. Phytate (1.35%), Oxalate (1.12%) and Tannin (0.02%) respectively. The overall results suggest that P. tetragonolobus leaves is of high nutritional quality due to high Crude protein and mineral contents with low presence of anti-nutritional factors.

Open Access Original Research Article

Study of Bacterial Resistance in Clinical Isolates of Staphylococcus aureus by Comparison of Conventional in-vitro Methods with PCR & RFLP Based Genotypic Methods

K. Muddukrishnaiah, S. Krishnan

Journal of Pharmaceutical Research International, Page 1-8
DOI: 10.9734/BJPR/2016/23303

Methicillin Resistant S. aureus is an increasingly common cause of nosocomial infections, causing severe morbidity and mortality worldwide and accounting for more than 50% of all S. aureus diseases. S. aureus used in our study were procured isolates from the microbiology lab of a corporate hospital. Reference culture of S. aureus NCIM 5021 was obtained from NCIM, Pune. Clinical isolates were subjected to antimicrobial susceptibility testing by standard antibiotic disc (Cefoxitin 30 µg). The selected clinical strains were tested for sensitivity to different antibiotics by Kirby Bauer disc diffusion method. The MIC was determined by two fold serial dilution in broth individually against various antibacterial agents. That was followed by a study on a combination of Ciprofloxacin & Linezolid by two dimensional checkerboard method of synergism testing against the clinical isolates and reference S. aureus NCIM culture. FIC index of combination indicated synergism against MRSA. MRSA was used for PCR based study of the resistant gene namely mecA. PCR-RFLP method was used to study 16S rRNA by restriction digestion using Taq 1. This is indicative of the possible serological differences among clinical isolates and was compared to NCIM culture based on restriction fragments.

Open Access Original Research Article

Factor Affecting Photo and Thermal Stability of Levothyroxine Sodium

Siham Abdallah, Ishraqa Mohamed

Journal of Pharmaceutical Research International, Page 1-11
DOI: 10.9734/BJPR/2016/23410

The aim of this works is to study the thermal and photo-decomposition of levothyroxine sodium.

The effect of light on the stability of the drug in solution was studied under conditions of several parameters (concentration and pH).

Photo-decomposition was carried out by exposing the drug to direct sunlight, while thermal decomposition was carried out by heating the drug at different temperatures.

Quantitative measures were carried out using high performance liquid chromatography (HPLC).

Light was found to have a significant effect on the drug stability while temperature has a negligible effect at the same exposure time.

The exposure of levothyroxine sodium in solution form to direct sunlight for 80 min resulted in more than 60% decomposition. On the other hand, temperature of up to 100°C has no effect. The drug seems to be stable in acidic medium.

Attempts to isolate the photo-decomposition degradation products of the drug were made.

The photo-decomposition of the drug was found to follow zero-order kinetics with correlation coefficient of 0.98.

Levothyroxine sodium undergoes photo-decomposition reaction and is not stable in the presence of sunlight.

Unless the manufacturing process is carefully consistently controlled, orally administrated levothyroxine sodium products may not be fully potent through the label expiration date.

Open Access Original Research Article

Assessment of Entrepreneurial Traits and Intention of Pharmacy Students in Obafemi Awolowo University, Ile-Ife, Nigeria

M. O. Afolabi, O. J. Ola-Olorun, I. O. Abereijo, V. I. Uchegbu

Journal of Pharmaceutical Research International, Page 1-11
DOI: 10.9734/BJPR/2016/22855

Background: Sub-optimisation in utilisation of professional skills often poses major practice challenge to young pharmacists in institutional health care settings hence the need to redirect their focus to employment-promoting strategies such as entrepreneurship.

Aims: The aims of the study were to explore the level of entrepreneurial traits and possession of future entrepreneurship intention among pharmacy undergraduates of Obafemi Awolowo University and to identify the factors that may influence their propensity towards self employment.

Study Design: A cross-sectional descriptive survey.

Place and Duration of Study: Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy; Obafemi Awolowo University, Ile-Ife. Nigeria from July, 2012 to February, 2013.

Methods: Two hundred and fifteen of the 628 pharmacy undergraduates of the university were selected by stratified random sampling. Pre-tested semi-structured questionnaire was used to collect primary data. The level of entrepreneurial traits was measured on a five point Likert-type scale with alternative responses of very low (1), low (2), moderate (3), high (4) and very high (5). Future entrepreneurial intention was measured using items with dichotomous ‘yes’/‘no’ responses. Collected data were analysed using descriptive and inferential statistics such as frequencies, percentages, weighted averages, mean of weighted averages (MWA) and chi square.

Results: The level of entrepreneurial traits of the students was found to be 4 (MWA = 3.9) while majority (79.67%) of the responses for future entrepreneurial intention was in the affirmative. The most prominent factors perceived by respondents as determining future entrepreneurial intention were ‘preference for personal creativity’ (63.3%) and ‘lack of security in the country’ (28.8%) for motivator and barrier respectively. Chi-square test showed that gender was significantly associated with some entrepreneurial traits namely propensity for risk-taking, willingness to take calculated risks and ability to formulate an effective venture team.

Conclusion: The study concluded that the level of entrepreneurial traits of the students was high and they possessed future entrepreneurial intention. The entrepreneurial traits of the students can be appropriately deployed and their intention actualized by incorporating entrepreneurial studies in pharmacy undergraduate curriculum.