Generic versus innovator: Analysis of the pharmaceutical qualities of paracetamol and ibuprofen

The physicochemical equivalence of twenty-two brands of paracetamol and nine brands of ibuprofen tablets sourced from retail Pharmacy outlets in the Nigerian market to their respective innovator brands were investigated. The uniformity of weight, friability, crushing strength, disintegration and dissolution times and assay of active paracetamol ingredient were used as assessment parameters. All the brands of paracetamol and ibuprofen tablets complied with the official specifications for uniformity of weight. However, five brands of paracetamol failed the friability test, one brand of paracetamol and two brands of ibuprofen failed the disintegration test and three brands of paracetamol and four brands of ibuprofen failed the assay of active ingredients. The study shows that not all the brands of paracetamol and ibuprofen tablets are physico-chemically equivalent to their innovator brands. There is therefore the need for constant market surveillance to ascertain their compliance with official standards and equivalence to the innovator products. Keywords: Generic, innovator brand, paracetamol, ibuprofen, physicochemical equivalence East Central African Journal of Pharmaceutical Sciences Vol. 12 (2009) 55-6

Development of a Visible Spectrophotometric Method for the Analysis of Ganciclovir in Bulk Sample and Dosage Form

Purpose: To develop and validate a simple visible spectrophotometric method for the quantitative determination of ganciclovir in bulk sample and dosage form.Method: The method was based on the diazo coupling reaction between diazotized ganciclovir and acidified p-dimethylaminobenzaldehyde. Various analytical parameters for the azo adduct were established. Validation of the new method was carried out using current ICH guidelines with parameters including linearity, repeatability, reproducibility and selectivity determined. The developed method was thereafter applied to determine ganciclovir in a commonly available brand.Results: Coupling reaction generated a yellow-coloured product in an alcohol medium with optimal wavelength at 404 nm. Linear correlation was obtained at concentrations of 10.3 - 25.7 μg/mL. The method was accurate and precise with recovery in the range of 99.37 - 103.15 % while intra- and interday precision (% RSD) at three different concentrations was < 2.7 %. The limits of detection and quantification were 0.23 and 0.70 μg/mL, respectively. When applied to the analysis of the dosage form, there was no statistically significant difference between the new method and the official HPLC method.Conclusion: The method is simple, inexpensive, reproducible and fast, and can be employed as a reliable alternative to the official method for the routine analysis of ganciclovir in bulk and dosage forms.Keywords: Ganciclovir, p-dimethylaminobenzaldehyde, Diazo coupling reaction, Absorption spectrophotometr

A Novel Derivatization Ultraviolet Spectrophotometric Method for the Determination of Dihydroartemisinin using p- Nitroaniline

Purpose: To develop a novel ultraviolet (UV)–spectrophotometric method for the determination of dihydroartemisinin (DHA) in tablets using  p-nitroaniline (PNA) as a derivatizing agent.Methods: Derivatization was based on the reaction between methanol solutions of dihydroartemisinin (DHA) and p-nitroaniline (PNA) in acid medium (1M HCI) at elevated temperature and for a short reaction time. Optimal detector response was obtained within 15 min when the reaction was carried out at 90 0C in a molar ratio of 2:1 (DHA:PNA). The method used for analysis was validated and a linear calibration curve constructed in the range of 30 – 100 ìg/mL for the reaction mixture at an absorbanceof 290 nm.Results: Separation of adduct from PNA was better achieved on reversed phase thin layer chromatography (TLC) using acetonitrile : water (60:50) or on high performance liquid chromatography (HPLC) with retention times of 2.8 min for PNA and 5.8 min for the adduct. The limit of detection was 6ìg/mL. The method was precise and accurate in the range 100.70 - 100.96 %, with intraday and interday precisions of less than 2 % at concentrations of 40 and 80 ìg/mL, respectively. The new method was applied to the assay of two brands of dihydroartemisinin tablets with accuracy similar tothat of the International Pharmacopoeia (IP) UV-spectrophotometric method (p > 0.05).Conclusion: The derivatization method is simple, direct, devoid of dilutions and inexpensive in terms of reagent requirements and analyte volume, and has a shorter reaction time, cpmpared with IP method. Based on the foregoing, the method can be adopted as an alternative to the official assay method for routine quality control of dihydroartemisinin tablets.Keywords: Derivatization, Ultraviolet spectrophotometry,  Dihydroartemisinin, p-Nitroaniline, Analysis, Assay, Quality contro

Quality of life of mothers of children with cerebral palsy and their agematched controls

Background Caring for a child with cerebral palsy (CP) could negatively impact the quality of life (QoL) of the mothers who are usually the primary caregivers. Studies on the impact of caring for Nigerian children with cerebral palsy on the mothers’ quality of life are not common hence the quality of life of mothers of children with cerebral palsy (MCCP) and age-matched mothers of typically developing children (MTDC) were compared in this study.Methods Eighty mothers (40 MCCP and 40 MTDC) participated in this cross-sectional survey. Participants in both groups had their quality of life assessed using the World Health Organization Quality of Life BREF (WHOQoL-BREF). Data were analyzed using independent t-test, Chi-square and Mann-Whitney U tests with alpha level set at 0.05.Results The two groups were not significantly different in their ages (p = 0.14). The mean overall QoL score of the MCCP (62.83±17.83) was significantly lower than that of the MTDC (68.87±8.51) (U=590.0; p=0.04) just as scores for overall health perception (U=576.5; p=0.03). Religion, educational status and occupational status had no significant influence on the QoL scores of mothers of children with cerebral palsy.Conclusion Caring for a child with CP significantly impacted on the QOL and health of the mothers, irrespective of their socio-economic status. Measures to improve quality of life and health of mothers of children with cerebral palsy should be incorporated in the management of CP with emphasis on identified areas of need.Key words: Caregivers, Cerebral Palsy, Quality of Life, Typically Developing Childre

Colorimetric Assay Of Naproxen Tablets by Derivatization Using 4-Carboxyl-2,6-Dinitrobenzene Diazonium Ion

A colorimetric assay of naproxen tablets based on chemical derivatization with the chromogenic reagent 4-carboxyl-2,6-dinitrobenzene diazonium ion was developed. The optimal reaction time was found to be 5 min at 30 oC after vortex mixing of the drug/reagent mixture for 10 s. The optimal analytical wavelength was found to be 470 nm and linearity of response was obtained between 1-7 μgml-1 of naproxen. The diazo coupling reaction occurred in a 2:1 reagent-drug stoichiometric ratio. The method is sensitive, accurate (mean recovery 101.06±3.06 %), reproducible (imprecision 3.03 % CV) and has a low limit of detection (0.95 μgm-1). It was applied in the assay of naproxen tablets with equivalent accuracy (p>0.05) to the official (BP) UV spectrophotometric method but combined the advantages of speed and more affordable instrumentation. The method can be applied in the in-process quality control of naproxen tablets.Keywords: Naproxen assay, 4-carboxyl-2,6-dintrobenzene diazonium ion (CDNBD), colorimetry, diazo coupling reactionEast and Central African Journal of Pharmaceutical Sciences Vol. 12 (2009) 8-1

Antibiotic Susceptibility Pattern and Beta-lactamase Production in Isolates of Staphylococcus aureus from Recurrent Furunculosis in Southwestern, Nigeria

Furuculosis is a skin infection caused by Staphylococcus aureus. It is characterised by honey crusted ‘cropped’ latent boil with potential to recur in a susceptible host. Isolates of S.aureus obtained from both hospitalised and non-hospitalised patients with furuncles in Southwest, Nigeria were characterised in relation to their resistance to commonly used antimicrobial agents. Exudates of ‘cropped-boils’ from one hundred and forty (140) individuals consisting of forty (40) hospitalised and one hundred (100) non-hospitalised cases of recurrent furunculosis were screened for S. aureus. One hundred and two (102) were positive for the organism by conventional biochemical tests. Detection of β-Iactamase was determined by cell-suspension iodometric method. Of the 102 isolates, 30(29.4%) strains possessed β-lactamase and the minimum inhibitory concentration (MIC) of selected antibiotics was in the range of 3.95– 250μg/ml. The multiple drug resistance as evident in high MICs of the antibiotics tested could probably be due to abuse/misuse of antibiotics resulting in recurrence of furuncles in the patients

Effectiveness of Azadirachta indica A. Juss (Neem) Seed Oil in Controlling Wood Termite

The protection of wood against biodeteriorating agents like termite during processing or in service has call for serious possible approach using new safer, environmental friendly preservatives hence this study therefore evaluated Azadirachta indica seed oil against termite attack on Gmelina arborea and Triplochiton scleroxylon wood. The seed oil was obtained using a soxhlet apparatus and N-hexane as the solvent. The wood was dimensioned into 20x20x20 mm and the seed oil was applied by brushing, dipping and soaking and exposed to termitarium while the absorption rate and weight loss to termite attack were determined. Data collected was analyzed using simple statistics and analysis of variance at \u3b10.05. The antimicrobial properties of the need seed oil are due to the availability of phytochemicals which promote antimicrobial activity. The maximum wood protection against termite of all the methods of application was obtained from soaking. The absorption and weight loss ranged from 11.20 - 43.88 % and 56.50 -61.58 % for G. arborea and T. scleroxylon respectively. However, all the application methods used for the wood treatment proved to be effective over the untreated wood

Correlation between placenta and umbilical cord morphplogy and perinatal outcome in singleton deliveries at term in a Nigerian tertiary health centre

Context: The ability of the fetus to grow and thrive in-utero depends on a number of factors of which the placenta is a contributor. The umbilical cord is an essential organ connecting the fetus to the placenta and a healthy placenta is essential for good perinatal outcome.Objectives: The study aims at determining the relationship between the morphology of the placenta and umbilical cord and perinatal outcome in singleton deliveries at term in a Nigerian hospital.Study design:This is a cross-sectional study involving the analysis of placentae and umbilical cords of three hundred and five neonates delivered in the Federal Medical Centre, Owo who met the inclusion criteria. Immediately after each delivery, the umbilical cord was clamped and severed five centimetres from its attachment to the neonate. The rest of the umbilical cord from the cut end to its insertion on the placenta was measured in centimetres and five centimetres of the umbilical cord attached to the neonate was added to get the entire length of the umbilical cord. Other parametersinvolving the morphology of the umbilical cord and placentae were also noted.Outcome measures: Correlation between the morphological parameters of the umbilical cord, placenta and the neonatal factors such as Apgar scores, birth weight, length of the baby, admission into Neonatal Intensive Care Unit and its indication were determined.Results: Three hundred and five women had their babies' placentae and umbilical cords examined and also had other records complete. There were 270 umbilical cords out of the 305 recruited with normal coiling index range of 0.17-0.20 coils per centimetres giving an incidence of 88.5%. There was a positive correlation between birth weight and placenta weight (r = 0.466; p value <0.001); there was also a positive correlation between birth length and umbilical cord length (r = 0.130; p value <0.024); likewise there was a positive correlation between umbilical cord coiling index and some parameters of assessing perinatal outcome like the Apgar scores at first and fifth minute (r = 0.137; p value 0.024 and r = 0.84; p value 0.167 respectively) while it had a negative correlation with birth weight (r = -0.130;p = 0.024) .Conclusion: The findings from this study contribute significantly to knowledge and have also helped to establish the correlation between the intrauterine and extrauterine wellbeing

Effect of Cassava based diet on lipids concentration in albino rats fed with crude oil contaminated diet

The study was carried out to ascertain the effect of a cassava based diet (gari) on lipid profile in albino rats fed crude oil contaminated diets by feeding diet contaminated with various concentrations of crude oil mixed with 20% gari to albino rats to determine the protective effect of gari. The lipid profile (Cholesterol, triglycerides, HDL cholesterol and LDL cholesterol) were monitored in the animals. Gari feeding at 20% caused dose dependent reduction in Cholesterol and LDL cholesterol with dose dependent increases in Triglycerides and HDL cholesterol in gari fed albino rats compared with Petroleum fed albino rats (P<0.05) suggesting that gari reversed the effect of crude oil on changes in lipid profile. Dose dependent increase in cholesterol, LDL cholesterol and dose dependent decrease triglycerides and HDL cholesterol was observed in petroleum fed rats compared with their controls (P<0.05). The study showed that ingestion of petroleum contaminated diet caused increase cholesterol and LDL cholesterol and decreased triglycerides and HDL cholesterol, but supplementation of the diet with 20%Gari lowered the increased concentrations of cholesterol and LDL cholesterol observed in the Petroleum contaminated diet while increasing the triglycerides and HDL cholesterol concentrations. This study showed that feeding on gari diet caused reversed to changes in lipid concentration caused by crude petroleum

Test-retest reliability of IPAQ environmental- module in an African population

<p>Abstract</p> <p>Background</p> <p>There is overwhelming evidence of the benefits of physical activity and the physical environment is increasingly recognized as a promising determinant of physical activity participation. The influence of the environment on physical activity has not been evaluated among black Africans and no specific measure exists for assessing environmental factors related to physical activity in an African environment. The IPAQ E- module was designed to assess environmental factors for physical activity participation and was considered to be relevant to all countries regardless of the stage of economic development. The objective of this study was to assess the test- retest reliability of IPAQ E- module in an African population.</p> <p>Methods</p> <p>One hundred and three clinical students of a University in Nigeria were invited to participate in the reliability testing of IPAQ E- module. Sixteen of the 17- items on the environmental measure were assessed for test- retest reliability using intraclass correlation coefficient (ICC) with 95% Confidence interval (CI) overall and by gender. The measure addressed items regarding residential density, access to destinations, neighborhood infrastructures, aesthetic qualities, social environment, street connectivity and neighborhood safety.</p> <p>Results</p> <p>Of the total respondents, 51.5% were males and 48.5% were females. Overall, the intraclass correlation coefficient (ICC) ranged from 0.43 to 0.91. The item regarding many interesting things to look at (aesthetic) produced the overall highest reliability score (ICC = 0.91, 95% CI = 0.86 – 0.94), while the item regarding safety from crime during the day (neighborhood safety) produced the lowest overall score (ICC = 0.43, 95% CI = 0.26 – 0.57). Reliability of items on neighborhood infrastructures ranged between substantial agreement to almost perfect agreement overall (ICC = 0.66 – 0.88) and by gender (male- ICC = 0.68 – 0.90 and female- ICC = 0.63 – 0.86). The access to destination items (ICC = 0.49 – 0.74), social environment (ICC = 0.62) and street connectivity (ICC = 0.78) all had acceptable reliability overall. Meaningful differences were found between males and females on two items on neighborhood safety and one item on access to destinations.</p> <p>Conclusion</p> <p>The test- retest of IPAQ E- module resulted in moderate to almost perfect agreement for most of the items with few meaningful differences by gender. Environmental items of physical activity in an African population exhibited reliability similar to that in other environments. These results suggest that IPAQ E- module may be a useful measure for assessing environmental correlates of physical activity among population in Africa.</p