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Formulation Development of Generic Omeprazole 20 mg Enteric Coated Tablets  [PDF]
Christopher Oswald Migoha, Eliangiringa Kaale, Godliver Kagashe
Pharmacology & Pharmacy (PP) , 2015, DOI: 10.4236/pp.2015.67031
Abstract: Omeprazole is a potent proton pump inhibitor with powerful inhibition of secretion of gastric juice. Oral site-specific drug delivery systems have recently attracted a great interest for the local treatment of bowel disease and for improving systemic absorption of drugs which are unstable in the stomach. However, microenvironment in the gastrointestinal tract and varying absorption mechanisms cause hindrance for the formulation and optimization of oral drug delivery. The objective of the study was to develop and optimize enteric coating process for omeprazole tablets. Different batches of core tablets were sub coated, one set sub coated with opadry and another with a mixture of light magnesium oxide, magnesium stearate and absolute alcohol omeprazole magnesium. Seal coating was applied by using opadry to achieve certain weight gain and to protect omeprazole from acidic coating polymers. A comparative dissolution test was performed. The variation of thickness and diameter were observed to be minimal with a weight gain of 3% - 4% of enteric polymer. Disintegration test showed that in each tested batch the enteric coated layer remained intact in 0.1N HCl for 2 hours and when exposed to alkaline media of phosphate buffer pH 6.8, it dissolved within few minutes. Dissolution release was 98.8% to 102.4% within two hours when the product was exposed to phosphate buffer pH 6.8 after 2 hours. The similarity and dis-similarity factors were calculated and observed to be 54 to 61 and 4 to 5 respectively. Therefore a simple and good enteric coating process was developed and tested with potential for transfer this technology into local pharmaceutical industries using cheap and easily available materials.
Priority setting for the implementation of artemisinin-based combination therapy policy in Tanzania: evaluation against the accountability for reasonableness framework
Amani Mori, Eliangiringa Kaale
Implementation Science , 2012, DOI: 10.1186/1748-5908-7-18
Abstract: This paper describes the priority-setting process, which involved the selection of a new first-line antimalarial drug in the implementation of artemisinin-based combination therapy policy. These descriptions were further evaluated against the four conditions of the accountability for reasonableness framework. According to this framework, fair decisions must satisfy a set of publicity, relevance, appeals, and revision and enforcement conditions.In-depth interviews were held with key informants using pretested interview guides, supplemented with a review of the treatment guideline. Purposeful sampling was used in order to explore the perceptions of people with different backgrounds and perspectives. The analysis followed an editing organising style.Publicity: The selection decision of artemether-lumefantrine but not the rationale behind it was publicised through radio, television, and newspaper channels in the national language, Swahili. Relevance: The decision was grounded on evidences of clinical efficacy, safety, affordability, and formulation profile. Stakeholders were not adequately involved. There was neither an appeals mechanism to challenge the decision nor enforcement mechanisms to guarantee fairness of the decision outcomes.The priority-setting decision to use artemether-lumefantrine as the first-line antimalarial drug failed to satisfy the four conditions of the accountability for reasonableness framework. In our understanding, this is the first study to evaluate priority-setting decisions for new drugs in Tanzania against the accountability for reasonableness framework. In addition to the demand for enhanced stakeholder involvement, publicity, and transparency, the study also calls for the institution of formal appeals, revision, and regulatory mechanisms in the future change of malaria treatment policies.Malaria case management with pharmaceuticals is a major challenge in many malaria-endemic countries. Old but cheap and effective medicines are increasing
Investigation of Contributing Factors to Scombroid Fish Poisoning among Dar es Salaam City Residents in Tanzania  [PDF]
Ngwengwe Bulula, Veronica Mugoyela, Eliangiringa Kaale
Open Access Library Journal (OALib Journal) , 2017, DOI: 10.4236/oalib.1103992
Scombroid fish poisoning is a mild to moderate form of food poisoning caused by eating spoiled or bacterial contaminated fish after capture or during subsequent handling and storage. Its symptoms are similar to those of fish allergy though it gives negative results to allergy tests. Because of that, most clinicians misdiagnose scombroid or histamine fish poisoning, and erroneously advise their patients never to eat the same fish again. A prospective descriptive cross-sectional study was carried out to assess the contributing factors of scombroid fish poisoning among fish consumers and health care personnel residents in Dar es Salaam. Results showed 49.6% of fish consumers and 60% of health care workers were aware of scombroid fish poisoning. Among those with awareness, 2.2% of fish consumers had average knowledge and the remainder had low knowledge, while 6.3% of health care workers had good knowledge, and 42.9% and 50.8% had average to low knowledge, respectively. Mackerel was frequently listed among the scombroid fish associated with scombroid fish poisoning followed by tuna and king fish. Rashes (59%), diarrhoea (21.6%) and skin itching (19.4%) were the frequently mentioned symptoms by respondents. Aggressive health promotion interventions should be designed and implemented to increase awareness of histamine fish poisoning to general public including the health care personnel.
Development of a Qualitative near Infrared Screening Method for Quality Consistency Assessment of Virgin Sunflower Oil  [PDF]
Fredrick Luyangi, Eliangiringa Kaale, Vicky Manyanga, Veronica Mugoyela
Spectral Analysis Review (SAR) , 2017, DOI: 10.4236/sar.2017.53003
Abstract: Near infrared spectroscopy offers advantages in the analysis of vegetable oils such as rapidity, relative cost-effectiveness, and usually no need for sample preparation. Virgin Sunflower oils were used as reference standards to develop spectra library for qualitative identification and validation of the method. This model was validated by correct classification method using positive and negative control samples. Various market samples of virgin sunflower oil were purchased and compared with spectra library. The results of spectral analysis of reference library and market samples were correlated using Mahalanobis distance method. Analysis involved 22 market samples. When these samples were matched against calibration samples, 4 samples out of 22 which are about 18.2% were not matched by the reference model. These market samples had Mahalanobis distance values between 4.2 and 6.7, which are greater than maximum permissible value of 3. Some of adulterants mentioned were Korie oil and pumpkin seeds oil.
Assessment of Medicines Cold Chain Storage Conformity with the World Health Organization Requirements in Health Facilities in Tanzania  [PDF]
Siya Ringo, Veronica Mugoyela, Eliangiringa Kaale, Joseph Sempombe
Pharmacology & Pharmacy (PP) , 2017, DOI: 10.4236/pp.2017.810024
A descriptive study on assessment of medicines cold chain storage conformity with World Health Organization (WHO) requirements in public health facilities was carried out in Dar es Salaam and Dodoma regions. Storage conformity in selected health facilities was assessed by monitoring temperature using temperature data loggers mounted in the refrigerators for a period of 30 days. Results indicated almost half of the health facilities 48.5% visited, did not significantly (P = 0.031) comply with storage temperature (+2°C to +8°C) as per WHO requirement because all recorded Mean Kinetic temperature (MKT) > 8°C. In rural areas, 59.2% of visited health facilities adhered to the WHO recommended storage temperature while in urban areas only 31.6% complied. The study has established electricity failure in urban and lack of gas in rural areas coupled with absence of contingency plan as major challenges to WHO temperature conformity in storage of cold chain medicines in health facilities in Tanzania.
The Role of Evidence in the Decision-Making Process of Selecting Essential Medicines in Developing Countries: The Case of Tanzania
Amani Thomas Mori, Eliangiringa Amos Kaale, Frida Ngalesoni, Ole Frithjof Norheim, Bjarne Robberstad
PLOS ONE , 2014, DOI: 10.1371/journal.pone.0084824
Abstract: Background Insufficient access to essential medicines is a major health challenge in developing countries. Despite the importance of Standard Treatment Guidelines and National Essential Medicine Lists in facilitating access to medicines, little is known about how they are updated. This study aims to describe the process of updating the Standard Treatment Guidelines and National Essential Medicine List in Tanzania and further examines the criteria and the underlying evidence used in decision-making. Methods This is a qualitative study in which data were collected by in-depth interviews and document reviews. Interviews were conducted with 18 key informants who were involved in updating the Standard Treatment Guidelines and National Essential Medicine List. We used a thematic content approach to analyse the data. Findings The Standard Treatment Guidelines and National Essential Medicine List was updated by committees of experts who were recruited mostly from referral hospitals and the Ministry of Health and Social Welfare. Efficacy, safety, availability and affordability were the most frequently utilised criteria in decision-making, although these were largely based on experience rather than evidence. In addition, recommendations from international guidelines and medicine promotions also influenced decision-making. Cost-effectiveness, despite being an important criterion for formulary decisions, was not utilised. Conclusions Recent decisions about the selection of essential medicines in Tanzania were made by committees of experts who largely used experience and discretionary judgement, leaving evidence with only a limited role in decision-making process. There may be several reasons for the current limited use of evidence in decision-making, but one hypothesis that remains to be explored is whether training experts in evidence-based decision-making would lead to a better and more explicit use of evidence.
Pre-Formulation Development of Lamivudine 300 mg and Tenofovir Disoproxil Fumarate (TDF) 300 mg Fixed Dose Combination Tablets  [PDF]
Prosper Tibalinda, Dickson Pius, Raphael Shedafa, Nelson Masota, Mary Temu, Eliangiringa Kaale
Pharmacology & Pharmacy (PP) , 2016, DOI: 10.4236/pp.2016.77031
Abstract: Introduction: In this study, physical and chemical characteristics of Lamivudine, Tenofovir Disoproxil Fumarate (TDF) and potential excipients were systematically followed and documented [1]. Objective: The objective of this scientific work was to carry out pre-formulation studies including compatibility studies on Lamivudine and Tenofovir Disoproxil Fumarate with their potential excipients prior a direct compression process [2]. Methodology: The interaction was studied in three set of environments namely uncontrolled room conditions for Zone VI b (30°C ± 2°C), oven conditions in which the oven was set at 50°C and accelerated climatic conditions in which a climatic chamber was set at 40°C ± 2°C/75% ± 5% Relative Humidity (RH %). Sample preparation was done by mixing the amount of formulation excipients to active substances at a ratio of 1:10, whereas active substance to another active substance at a ratio of 1:1, active substance to coating materials at 1:4, coating materials to the whole set of excipients 1:4. The whole set of samples was geometrically mixed and triturated by mortar and pestle to very fine uniform powder to ensure homogeneity of the mixture. HPLC analytical method was used for simultaneous quantitative determination of lamivudine and tenofovir disoproxil fumarate. Transmittance of the mixture was determined by Near Infra-Red (NIR) technique. Results: The amount of Lamivudine as on day 0 was comparable to day 90 for in all tested conditions (Room, Oven and Climatic Chamber), whereas for Tenofovir Disoproxil Fumarate only the amount of the drug at Room (30°C ± 2°C) was comparable to results on day 90. A significant drop of amount of Tenofovir Disoproxil Fumarate (TDF) exposed to moisture (Climatic chamber at 40°C ± 2°C/75% ± 5% Relative Humidity (RH %)) and temperature of 50°C was observed. Colour change was observed for samples subjected to moisture (Climatic chamber at 40°C ± 2°C/75% ± 5% Relative Humidity (RH %)) and as well picked up in the NIR region 400 to 1500 cm-1 (Finger print region) by a significant shift in
Assessment of Moisture Permeability and Closure Systems of High Density Polyethylene Plastic Bottles Used as Primary Packaging Containers for Moisture Sensitive Medicines  [PDF]
Raphael Shedafa, Prosper Tibalinda, Vicky Manyanga, Joseph Sempombe, Marry Temu, Nelson Masota, Eliangiringa Kaale, Christoph Bonsmann
Pharmacology & Pharmacy (PP) , 2016, DOI: 10.4236/pp.2016.78039
Abstract: Introduction: Moisture permeability and a loose closure system might allow a significant gain of moisture into container and this could lead to significant loss of potency of drug sensitive to moisture and as well promoting the growth of microorganisms. Typical examples of the drugs sensitive to moisture include Tenofovir Disoproxil Fumarate (TDF). Product claimed to be a “Tight container” does not make it a tight container until proved practically. A plastic container is tight if “not more than one of the 10 tested containers exceeds 100 mg per day per L in moisture permeability. Objectives: The goal of this study was to determine rate of moisture permeability of selected High Density Polyethylene plastic bottles for packaging of moisture sensitive medicines in particular Lamivudine/Tenofovir Disoproxil fumarate tablets. Methodology: The determination of rate of moisture permeability was achieved by assessing closure systems of plastics as per USP 37 <671> method, while the difference in absorption pattern was achieved by assessing the spectrum obtained through transmittance by Fourier Transform-Infrared (FT-IR). The plastic bottles were randomly selected from supplier A, B and C. Results: The plastic bottles from supplier A and B had an average moisture permeability of 12.57 and 51.55 mg/day/L with none of the containers exceeding moisture permeability of 100 mg/day/L whereas containers from supplier C had an average of 149.95 mg/day/L with seven of the containers exceeding of 100 mg/day/L. Conclusion: Containers from supplier A and B met the USP specifications hence could be used as primary packaging for moisture sensitive medicines whereas the containers from supplier C did not meet the USP specifications for them to be regarded as “Tight Containers” and hence, unsuitable for packaging of moisture sensitive medicines.
Storage of antimalarials at household level and associated factors in Kiromo ward, Bagamoyo Tanzania
MJ Temu, E Kaale, M Marawiti
African Health Sciences , 2006,
Abstract: Background: Malaria is a highly debilitating and frequently fatal disease of wide distribution. Improper drug storage and rampant self-medication are some of the factors that may contribute to an increase in the development of drug resistance by malaria parasites towards antimalarials. Objectives: To determine the extent of antimalarial drugs storage, sources and associated factors at household level at Kiromo ward in Bagamoyo, Coast region, Tanzania after the introduction of SP replacing chloroquine as first line. Methods: A total of 300 households from three villages making up Kiromo ward were included in this study. Swahili version of the questionnaire and a checklist were used in data collection. Results: Of the 300 households visited 25 (8.3%) were found to store antimalarials. The most commonly stored antimalarials were amodiaquine (30.8%) and quinine (34.6%). Most of these were in tablet form (76.9%). The source of these drugs was mostly from dispensaries. Kiromo was the only dispensary in the ward and others were outside the ward. These drugs were stored in special containers for safety. Frequent episodes of illness in the family were given as the most (56%) common reasons for drug storage in the families, followed by distance (20%). There was a statistically significant (p<0.05) association between storage of antimalarial drugs and number of children in the family and presence of a family member with febrile illness. The study further showed that out of 26 different types of antimalarials stored, only 7 (26.9%) had expiry dates on the containers because these were original containers of the drugs. Conclusion: The study revealed that few households store antimalarial drugs with amodiaquine and quinine being the most stored. The majority of the households obtained antimalarial drugs from dispensaries. Health education should be given not only to the patients but also the entire general public on the appropriate drug use, safety, expiry dates and appropriate storage. A model dispensary like Kiromo should be implemented in other rural areas. African Health Sciences Vol. 6(1) 2006: 43-48
Change in basic motor abilities, quality of movement and everyday activities following intensive, goal-directed, activity-focused physiotherapy in a group setting for children with cerebral palsy
Anne Sorsdahl, Rolf Moe-Nilssen, Helga K Kaale, Jannike Rieber, Liv Strand
BMC Pediatrics , 2010, DOI: 10.1186/1471-2431-10-26
Abstract: A repeated measures design was applied with three baseline and two follow up assessments; immediately and three weeks after intervention. Twenty-two children with hemiplegia (n = 7), diplegia (n = 11), quadriplegia (n = 2) and ataxia (n = 2) participated, age ranging 3-9 y. All levels of Gross Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS) were represented. Parents and professionals participated in goal setting and training. ANOVA was used to analyse change over repeated measures.A main effect of time was shown in the primary outcome measure; Gross Motor Function Measure-66 (GMFM-66), mean change being 4.5 (p < 0.01) from last baseline to last follow up assessment. An interaction between time and GMFCS-levels was found, implying that children classified to GMFCS-levels I-II improved more than children classified to levels III-V. There were no main or interaction effects of age or anti-spastic medication. Change scores in the Pediatric Evaluation of Disability Inventory (PEDI) ranged 2.0-6.7, p < 0.01 in the Self-care domain of the Functional Skills dimension, and the Self-care and Mobility domains of the Caregiver Assistance dimension. The children's individual goals were on average attained, Mean Goal Attainment Scaling (GAS) T-score being 51.3. Non-significant improved scores on the Gross Motor Performance Measure (GMPM) and the Quality of Upper Extremities Skills Test (QUEST) were demonstrated. Significant improvement in GMPM scores were found in improved items of the GMFM, not in items that maintained the same score.Basic motor abilities and self-care improved in young children with CP after goal-directed activity-focused physiotherapy with involvement of their local environment, and their need for caregiver assistance in self-care and mobility decreased. The individualized training within a group context during a limited period of time was feasible and well-tolerated. The coherence between acquisition of basic motor
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