Open Access Original Research Article

Signal Detection and Clarification of Peripheral Neuropathy and Guillain-Barré Syndrome Associated with Exposure to Systemic Fluoroquinolones

Ayad K. Ali

Journal of Pharmaceutical Research International, Page 407-417
DOI: 10.9734/BJPR/2014/6954

Aims: Peripheral neuropathy (PN) is an identified risk of systemic antibacterial therapy with fluoroquinolones. The risk and its severity, including the development of Guillain-Barré syndrome (GBS) between individual agents is uncertain. This study examines the association between fluoroquinolones and PN and GBS in cases spontaneously reported to the FDA Adverse Event Reporting System (FAERS).
Study Design: Retrospective pharmacovigilance analysis.
Place and Duration of Study: Cases submitted to FAERS between 1997 and 2012.
Methodology: The MedDRA Preferred Term was used to define PN and GBS. Individual fluoroquinolones were identified by generic names and route of administration. Empirical Bayes Geometric Mean (EBGM) with 95% confidence interval (EB05-EB95) was calculated as disproportionality measure. Safety signals with EB05>2 was considered a significant disproportional increase in event reporting of at least twice times higher than expected.
Results: There were 539 PN reports out of 46,257 adverse event reports submitted for fluoroquinolones. 9% of PN reports were for GBS. Significant disproportionality of PN (EBGM 2.70; EB05-EB95 2.51-2.90) and GBS (EBGM 3.22; EB05-EB95 2.55-4.02) was identified for fluoroquinolones. Signals of PN were detected for ciprofloxacin (EBGM 3.24; EB05-EB95 2.87-3.66) and levofloxacin (EBGM 3.36; EB05-EB95 3.02-3.72). A GBS signal was detected for ciprofloxacin (EBGM 4.15; EB05-EB95 2.94-5.74). GBS and PN respectively ranked 6th and 8th among reported neurological events.
Conclusion: This study reemphasizes the link between fluoroquinolones and PN, and shows potential association with more severe forms of nerve damage, e.g. GBS. Unless the benefit of fluoroquinolone therapy outweighs PN risk, treatment with alternative antibacterial agents is recommended.

Open Access Original Research Article

UV Spectrophotometric Method for the Simultaneous Determination of Desloratidine and Pseudoephedrine HCl in Combined Dosage Form

K. Hussain Raviteja, Mahesh Nasare, V. V. L. N. Prasad, Prakash V. Diwan

Journal of Pharmaceutical Research International, Page 418-428
DOI: 10.9734/BJPR/2014/5615

Aims: UV Spectrophotometric Method for the Simultaneous Determination of Desloratidine and Pseudoephedrine HCl in combined Dosage form.
Study Design: A simple, rapid and specific UV spectroscopic method with good sensitivity was developed and validated for the simultaneous determination of Desloratidine and Pseudoephedrine HCl in bulk and pharmaceutical dosage form.
Place and Duration of Study: Department of pharmaceutical Analysis & Quality Assurance, School of Pharmacy, Anurag Group of Institutions, Venkatapur, R.R Dist, Andhra Pradesh, India during February 2013 and April 2013.
Methodology: Vierodt’s (Simultaneous equation) method was performed for Estimation of Desloratidine and Pseudoephedrine HCl in Pharmaceutical dosage form.
Results: In Ethanol the λmax of Desloratidine and Pseudoephedrine HCl was fixed as 240 and 258 nm respectively using a Shimadzu UV-Visible spectrophotometer. In this proposed method both drugs obeyed linearity within the concentration range of 5-30 μg/ml and 80-800 μg/ml for Desloratidine and Pseudoephedrine HCl respectively. The low RSD values indicate good precision and high recovery values indicate accuracy of the proposed method. The proposed method has been applied to the determination of drugs in commercial formulations. Assay results were in good agreement with label claim. The method was validated as per ICH guidliness.
Conclusion: The developed method was simple, accurate, precise, specific, sensitive and reproducible which can be efficiently and easily applied to pharmaceutical dosage forms

Open Access Original Research Article

Effects of Momordica charantia on Serum Lipid Profile, Serum Protein Levels and Selected Markers of Cardiovascular Damage in Diabetic Rats

Omobola A. Komolafe, David A. Ofusori, Olarinde S. Adewole, Julius B. Fakunle

Journal of Pharmaceutical Research International, Page 429-442
DOI: 10.9734/BJPR/2014/5320

Aims: To investigate the effects of M. charantia on serum lipid profile, serum protein concentration and selected markers of cardiovascular damage in streptozotocin-induced diabetic Wistar rats.
Study design: Forty healthy adult Wistar rats of both sexes were randomly assigned into five groups A, B, C, D and E of eight rats each.
Place and Duration of Study: Department of Anatomy and Cell Biology, Obafemi Awolowo University, Nigeria, between January 2010 and March 2012.
Methodology: At the expiration of the research, the animals were sacrificed and blood samples were collected for biochemical analysis. Serum lipid profile, total protein and serum albumin, serum Creatine Kinase, Lactate Dehydrogenase and Glucose-6-Phosphate Dehydrogenase activities were determined using Randox assay kits. The levels of Serum globulin and albumin/globulin ratio were calculated. Serum nitric Oxide and Prostaglandin E2 levels were determined using assay kits.
Results: The result showed a significant reduction (p<0.05) in the blood glucose levels in group D when compared with groups A, B, C and E. There was an increase in triglyceride (p<0.05), total cholesterol (p>0.05), low density lipoprotein (p>0.05) and very low density lipoprotein cholesterol (p<0.05) were increased in group B when compared with group D. The serum levels was presented a non significant reduction in total protein (p>0.05), albumin (p>0.05), globulin (p>0.05) and albumin/globulin ratio (p>0.05) when group B was compared with group D. Lactate dehydrogenase (F=0.18, p>0.05) and creatinine kinase (F=1.96, p>0.05) were increased (p>0.05) while the nitric oxide (F=2.21, p<0.05), PGE2 (F=1.25, p<0.05) and G6PDH (F=2.92, p<0.05) were reduced (p<0.05) in group B when compared with A, C, D and E.
Conclusion: The presents study thus suggests that M. charantia could serve as a useful antidiabetic agent.

Open Access Original Research Article

In vitro Cytotoxic Activity of Hydro Ethanolic Extract of Delonix regia (Bojer ex. Hook.) Flowers on Cancer Cell Lines

Madan R. Pusapati, Tejaswi Jonnalagadda, Phani K. Kola, Ankamma C. Yarlagadda, Girijasankar Guntuku

Journal of Pharmaceutical Research International, Page 443-452
DOI: 10.9734/BJPR/2014/5746

Aims: To evaluate the In vitro cytotoxic effects of the hydro ethanolic extract (HEE) of the Delonix regia flowers against different cell lines.
Methodology: The dried Delonix regia flowers are subjected to soxhlet extraction by using 70% ethanol. The dried extract was used to determine the qualitative preliminary phytochemical analysis, total phenolic and flavonoid content. The cytotoxic property of the extract was determined by using MTT assay against breast cancer (MCF-7), cervix (HeLa), brain and colon cancer cells. Tamoxifen is used as a standard for all the cell lines.
Results: Qualitative phytochemical tests of extract HEE showed the presence of sugars, flavonoid, tannins, phenolic compounds, steroids and saponins. The percentage of phenolic and flavonoid content was determined as 31.42 mg/g, 29.22 mg/g respectively. The cytotoxic activity of the extract showed, IC50 concentrations (μg/ml) against MCF-7 (breast), carcinoma of cervix HeLa cells, carcinoma of the brain, and carcinoma of colon cells against tamoxifen are 141.6 ± 0.08, 223.7 ± 2.16, 173.9 ± 0.7, 168.33 ± 0.04 respectively.
Conclusions: The experimental data clearly demonstrate the hydro ethanolic extract (HEE) showed cytotoxic properties against human cancer cells.

Open Access Original Research Article

Preparation and Characterization of Polymeric Mucoadhesive Film for Buccal Administration

Ramy B. Gales, Hassan M. Ghonaim, Ahmed R. Gardouh, Mamdouh M. Ghorab, Sabry S. Badawy

Journal of Pharmaceutical Research International, Page 453-476
DOI: 10.9734/BJPR/2014/5399

Objectives: Buccal films consist mainly of polymer that has a good mucoadhesive profile and plasticizer. A lot of polymers and plasticizers can be used to configure the mucoadhesive films as hydroxyethyl cellulose and glycerin respectively.
Material and Methods: Films prepared by dispersing the polymer, mixing it with plasticizer and pouring it in Petri dishes to be dried and cut finally. Physicochemical tests were used to evaluate the films. These tests are organoleptic evaluation and polymer and plasticizer selection, determination of rheological properties of polymers, film thickness, and determination of moisture content, determination of moisture uptake and evaluation of mechanical properties.
Results and Conclusions: It was found that films prepared from polyvinyl alcohol 2% (w/w) especially with the addition of propylene glycol 20% from the weight of the polymer have excellent characteristics. This formula has promising organoleptic and mechanical properties and its solution is Non-Newtonian pseudoplastic. Moreover, this formula is very thin and has moderate percent of moisture content and moisture uptake. Also, it has high elongation with moderate tensile strength. As a result, it is better to prepare the film by these ingredients to obtain an ideal mucoadhesive formula.

Open Access Original Research Article

Exploration of the Angiogenic Potential of Honey

R. M. Munshi, S. S. Bhalerao, S. A. Kalekar, T. A. Patil

Journal of Pharmaceutical Research International, Page 477-489
DOI: 10.9734/BJPR/2014/6930

Aims: The present study was conducted to confirm the angiogenic potential of honey using Chick Chorioallantoic Membrane (CAM), an in ovo model and to study its effect on Vascular Endothelial Growth Factor (VEGF) expression in the CAM tissue. Attempts were also made to identify the probable active constituents present in honey that contributed to its angiogenic potential.
Methodology: Honey was evaluated over concentrations ranging from 0.015 to 25% v/v and the extent of angiogenesis was quantified using stereomicroscopy. VEGF expression at transcript level was determined by RT-PCR. Erythropoietin and Heparin were used as positive and negative controls respectively. Four known constituents of honey viz., Glucose, Proline, Vitamin C and Hydrogen peroxide were tested by biochemical methods.

Results: New blood formation was seen at all the concentrations tested, however the pro-angiogenic effect was greater at lower concentrations. These results were significantly greater than that seen with erythropoietin, the positive control. VEGF mRNA expression in CAM tissue also demonstrated similar findings. Among the constituents tested, Vitamin C and Hydrogen peroxide were observed to be associated with the angiogenic effect of honey.
Conclusion: The study thus confirms the pro-angiogenic potential of honey at low concentrations. This effect is probably due to the presence of Hydrogen peroxide and Vitamin C and is mediated via alteration in VEGF expression.

Open Access Original Research Article

Wound Healing Activity of Ethanol Leaf Extract of Erythrina senegalensis

E. E. Ilodigwe, B. E. Okonkwo, C. A. Agbata, D. L. Ajaghaku, P. M. Eze

Journal of Pharmaceutical Research International, Page 531-540
DOI: 10.9734/BJPR/2014/7260

Aim: This study investigates the wound healing activity of ethanol leaf extract of Erythrina senegalensis using excision wound model on albino rats.
Methodology: Several herbal extract formulations were prepared with Petroleum Jelly ointment base. Cicatrin® powder (neomycin-bacitracin) was used as the positive control. The various ointment formulations were applied topically on the wounds daily for 21 days. Daily wound contraction and epithelialisation times were recorded for each group. The antibacterial activity of the extract was also evaluated against some bacteria species implicated in wound infections. The following test organisms were used: Staphylococcus aureus, Pseudomonas aeruginosa, klebsiella pneumoniae and Escherichia coli.
Results: The Phytochemical analysis revealed that alkaloids were abundant in the extract. The herbal ointment at various concentrations showed significant (P<.05) increase in percentage wound contraction on day 9 – 21 compared with the control group that received only the ointment base. The contraction produced by 40% w/w of the extract was similar to that of Cicatrin® powder on day 6 – 21. The results also revealed significant (P<.05) reduction in epithelialisation time exhibited by the extract treated animals compared to those of the control group. The result of antimicrobial studies showed that the extract inhibited the test organisms at concentrations ranging from 200 to 12.5 mg/mL. The Minimum Inhibitory Concentrations (MICs) of the extract on the test isolates was recorded at 25mg/mL for both S. aureus and E. coli and 6.25mg/ml for K. pneumoniae. P. aeruginosa showed no susceptibility to both the extract and the control drug at the concentrations evaluated.
Conclusion: The marked reduction of wound size and epithelialisation time by the extract is an indication of its wound healing potentials. Also, the antibacterial activity of this plant against bacterial species implicated in wound infections may contribute to the enhanced wound healing activity.