Research/Original Articles


Medication Errors in Administration of Chemotherapeutic Agents: an Observational Study

Maria Tavakoli-Ardakani, Somayeh Omidi, Azadeh Eshraghi, Jamshid Salamzadeh

Iranian Journal of Pharmaceutical Sciences, Vol. 9 No. 2 (2013), 1 April 2013, Page 1-11
https://doi.org/10.22037/ijps.v9.40890

Chemotherapy medication errors may lead to potentially harmful consequences while most of them could be preventable. This study aims to determine the incidence and type of drug handling and administration errors among the nurses and to identify possible contributing factors. Setting of the study was a teaching hospital affiliated to Shahid Beheshti University of Medical Sciences, Tehran, Iran. To attain the study objectives, an observational, cross-sectional study was performed in the haematology and oncology wards of the hospital. A checklist consisting of appropriate process of handling, preparation and administration of injectable chemotherapy agents was developed and used by a trained pharmacist. In addition, socio-demographic characteristics of nurses were recorded. The primary outcome was the number and type of medication errors in chemotherapy administration according to the prepared check lists. Overall, administration processes of 544 chemotherapy medications, consisting of 8322 error opportunities, were observed of which 2705 (32.5%) errors were detected. 52.8% (2926/5532), 15.5% (254/1635) and 26.5% (306/1155) of the errors were in the handling, preparation and injection stages, respectively. The top 5 drugs with the highest risk of errors were metotraxate 45.4% (20/44), fluorouracil 38.5% (439/1139), cyclophosphamide 37.1% (267/719), vincristine 34.8% (240/689) and etoposide 33.5% (125/373). Our results revealed a substantial occurrence rate of medication errors during preparation and administration of injectable chemotherapy agents, which are often made by nurses who fail to follow relevant nursing standards. This confirms that educational programs and advanced pharmaceutical care services are required for safe preparation and administration of intravenous chemotherapy agents.

Anti-inflammatory Activity of Essential Oil of Canarium Strictum Roxb

Ragunathan Muthuswamy, Senthamarai R

Iranian Journal of Pharmaceutical Sciences, Vol. 9 No. 2 (2013), 1 April 2013, Page 13-21
https://doi.org/10.22037/ijps.v9.40891

Canarium L., used in folk medicine as anti-inflammatory, antibacterial, antifungal, antitumor and heptoprotective and antioxidant and anti diabetic. The present study investigated the in vivo anti-inflammatory activity of essential oil obtained by hydro distillation of Black dammer resin of Canarium strictum Roxb. Anti-inflammatory activity of essential oil of Canarium strictum Roxb., EOCS (10-100 mg/kg) has been established by using the carrageenan (acute inflammation model) and formalin (chronic inflammation model) induced paw edema in mice. The dose dependent activity has been observed at the higher dose of EOCS 100 mg /kg (P<0.0001). EOCS exhibited momentous anti-inflammatory activity that was compared with standard drug diclofenac sodium in acute inflammatory animal models. The perceived anti-inflammatory activity might be due to inhibition of histamine, serotonin, kinins, substance P and prostaglandins, and bradykinin at the inflamed area. On the other hand, in the formalin test EOCS 100 mg /kg reduced chronic inflammation most effectively (P<0.0001). Our data supported that EOCS capable to inhibit the paw edema in acute and chronic inflammation in the experimental animal models can be evident to use this oil for the treatment of chronic and acute inflammatory disorders. More elaborate investigation is needed in this aspect and to correlate the possible effect of major terpene which it produced anti-inflammatory activity.

Validated UV-Vis Spectrophotometric Method for Determination of Gabapentin using Acetyl Acetone and Formaldehyde Reagents

Nurmaya Effendi, Kosman Rachmat, Passuke Akbar; Naid Tadjuddin

Iranian Journal of Pharmaceutical Sciences, Vol. 9 No. 2 (2013), 1 April 2013, Page 23-29
https://doi.org/10.22037/ijps.v9.40893

Gabapentin is an anticonvulsant widely used in the treatment of epilepsy.An accurate and validated spectrophotometric method was developed as an alternative method to determine gabapentin in pharmaceutical products. This is a simple, accurate, precise, selective and visible spectrophotometric method. The method is based on the measurement of drug absorbance as a result of yellow solution formation reaction between gabapentin and condensation products both from 2 molesacetyl acetone and 1 mole formaldehyde in basic condition (in boric buffer pH 9.5) at 55oC for 15 minutes. The detection was performed at 340 nm.This method is linear in the range of 10.8–80.0 μg/mL with correlation coefficient (r2) of 0.99954. The method was validated according to USP Category I requirements for gabapentin. The validation characteristics include accuracy and precision, linearity, range, limit of detection and limit of quantitation. The acceptance validation criteria were found in all cases.

The main objective of the present study was to formulate gastroretentive effervescent sustained release drug delivery systems of risperidone floating tablets with the help of Methocel® K15, Ethocel® standard 7FP premium, Eudragit ® RS100 sustained release polymers to improve its safety profile, bioavailability and patient compliance. Risperidone floating tablets were formulated by wet granulation technique by using citric acid and sodium bicarbonate as a gas generating agent. Methocel® K15, Ethocel® standard 7FP premium, Eudragit® RS 100 were used to formulate floating effervescent sustained release tablets. Preliminary trials were done to investigate matrix integrity and floating behavior. On the basis of preliminary trials, various formulations were designed to optimize the best formulation. The FDA recommended statistical approach was used to test dissolution equivalency. Preliminary studies showed better floating behavior, but poor matrix integrity with Methocel®K15 containing formulations. Moreover, Ethocel® standard 7FP premium and Eudragit® RS 100 containing formulations showed better matrix integrity but poor floating behavior. Formulations RSFTIII, RSFTVI, RSFTIX were optimized and showed the drug release for 10 hours. Dissolution equivalency was tested for optimized formulation and found equivalent. In vivo-study also showed gastric retention time more than 4 hours.

Chewable ferrous fumarate tablet is the best iron dosage form for children due to better compliance and lower teeth staining compared to the oral drop. Because of the different desirable properties of chewable tablets and the opposing effects of fillers on them, the mathematical experimental design was used as the formulation approach. Different series of formulations based on single filler (Lactose granule, mannitol granule, and three Avicels) were prepared and evaluated. The total filler percentage in formulation was kept constant at 40% and simplex lattice mixture design was used with percentages of each of the three selected fillers as factors and hardness, friability, and taste of the resulted tablets as responses. The statistical analysis and optimization were performed by Design Expert software using responses in suggested experimental runs. Two-way analysis of variance and Scheffe Post-Hoc test showed that both the type and amount of fillers were effective on hardness and had interaction. Avicel PH301 was selected as the filler for imparting higher hardness, and lactose and mannitol granules for imparting good taste and mouth feel to tablets. The proper models for the relationship between the three factors and each of the three responses were determined and the regarding equations were suggested. The mathematical optimization suggested the acceptable formulations of ferrous fumarate chewable tablets. The mathematical experimental design is suggested as a promising efficient method for optimization of pharmaceutical formulation projects with multiple goals.

Design, Development and In Vitro Characterization of Self Emulsifying Drug Delivery System for Irbesartan

Supriya Patil, Amol Shete, Vinit Patil, Rajendra Doijad

Iranian Journal of Pharmaceutical Sciences, Vol. 9 No. 2 (2013), 1 April 2013, Page 67-80
https://doi.org/10.22037/ijps.v9.40902

The objectives of present investigations were to optimize concentration of oil, surfactant and cosurfactant by pseudoternary phase diagrams and to develop a stable formulation of self emulsifying drug delivery system (SEDDS) in order to enhance the dissolution rate of poorly soluble Irbesartan (IBS) by SEDDS. Pseudoternary phase diagrams were constructed to identify the self emulsifying region. Four self emulsifying formulations were prepared using mixture of Capryol 90 as oil, Tween 80 as surfactant and PEG 400 as cosurfactant in various proportions. Optimized liquid SEDDS formulations were converted into free flowing powder by spray drying technique and evaluated for drug content, infrared spectroscopy (FTIR), differential scanning colorimetry (DSC), powder X-ray diffraction (PXRD), Zeta potential analysis, Particle size analysis, scanning electron microscopy(SEM),in vitro dissolution study and in vitro diffusion study. The results suggested that considerabl improvement in the dissolution rate of drug from optimized SEDDS formulation was attributed to decreased crystallinity, altered surface morphology and reduction in particle size. Optimal formulation of irbesartan SEDDS were successfully developed in this work. The study illustrated that potential use of SEDDS dispense lipid soluble drug by oral route.

Implications of Pharmacoeconomics for Iran National Health System

Abdol Majid Cheraghali

Iranian Journal of Pharmaceutical Sciences, Vol. 9 No. 2 (2013), 1 April 2013, Page 81-85
https://doi.org/10.22037/ijps.v9.40905

Like many other developing countries pharmacoeconomics and outcome research and its applications in national health system is a new but promising filed in Iran. Although decision makers of Iran national health system decided to use pharmacoeconomics in the decision making approach several hurdles including lack of reliable national data, lack of expertise and local experience are the main challenges in this filed. Recent activities in training graduate students in the field of health technology assessment in the universities could play a major role in advancing this field in Iran.

Lornoxicam Alone and with Selegiline Improves the Neuroprotective Effect and Cognition in Scopolamine Induced Neurodegeneration and Cognitive Impairment in Rats

Sainath Reddy K, Kaleem A.K, Sharvana Bhava B.S, Satish P, Aravind P, Venkateshwarlu E

Iranian Journal of Pharmaceutical Sciences, Vol. 9 No. 2 (2013), 1 April 2013, Page 87-101
https://doi.org/10.22037/ijps.v9.40906

Alzheimer is a progressive neurodegenerative disorder in which Oxidative stress plays a major role. The present study was designed to investigate Neuroprotective effect of Lornoxicam, Selegiline and co-administration of both drugs in Scopolamine induced cognitive impairment and neurodegeneration. Scopolamine (1.4mg/kg) was administered intraperitoniallyin male Wistar rats. Rectangular maze performance test was used to assess the memory performance test. Various biochemical parameters such as Catalase, 1, 1-diphenyl-2- picrylhydrazine (DPPH), Thiobarbituric acid reactive substances(TBARS), reduced glutathione(GSH) and acetylcholine esterase (AchE) were also assessed. IntraperitonialScopolamine results marked memory impairment and oxidative damage. Sub-acute treatment with Lornoxicam (1.3mg/kg, p.o) and Selegiline (0.49mg/kg, p.o) and co-administration of these two drugs for 8 days significantly attenuated scopolamine induced oxidative damage and neurodegeneration. Besides, Lornoxicam, Selegiline and co-administration of both significantly reversed Scopolamine administered increase in acetylcholine esterase activity. Present study indicates protective effect of Lornoxicam, Selegiline and co-administration of both drugs against Scopolamine induced cognitive impairment and oxidative damage. The memory enhancing capacity of the drugs was very significant when compared with disease control (P <0.001).