23 research outputs found
Symposium - De la recherche à la production industrielle des produits de santé (Présentations d'expériences réussies) - Expérience n°3 : Processus de Recherche-Développement (R&D) et production d’un phytomédicament destiné au traitement de la drépanocytose : FACA
No full textDr Salfo OUEDRAOGO, PharmD, M.Sc. Pharma, PhD, Maître de Recherche en Pharmacie Galénique et Industrielle, Chef de service Production CNRST/IRSS/MEPHATRA/PH, Pharmacien chef de l’Unité de Production Pharmaceutique (U-PHARMA), Tel : (+226) 70 45 89 36/78 41 54 64
Résumé : Depuis l’antiquité, l’humanité a toujours recours aux plantes médicinales comme moyens de traitement adéquat, préventifs ou curatifs, plus ou moins efficaces qui sont perfectionnés sous le coup de recherches. Malgré les grands progrès observés dans la médecine moderne au cours des dernières décennies, les plantes médicinales jouent toujours un rôle clé dans la prise en charge des maladies. Certaines plantes utilisées au XVIIIe siècle sont toujours au cœur de la médecine et pharmacopée après que leur efficacité ait été scientifiquement démontrée. Dans ce contexte, plusieurs programmes sont développés par de nombreux centres pour la recherche de nouvelles molécules mais aussi pour la mise au point de médicaments à base de plantes.
Ce travail repose sur un retour d’expérience d’un praticien de la médecine traditionnelle qui utilisait une combinaison de deux plantes médicinales ((Zanthoxylum Zanthoxyloïdes Lam. (Rutaceae) Calotropis procera Ait. (Asclepiadaceae)) pour traiter la drépanocytose.
L’approche repose sur une démarche de la pharmacologie inverse. La première étape a consisté à réaliser une étude pharmacoclinique comparée à un traitement standard qui est la dihydroergotoxine (HYDERGINE®) chez des enfants en crise drépanocytaire. Les propriétés antifalciformantes ont été confirmés par des études in vitro. La deuxième étape a concerné les études chimiques et biologiques in
vitro et in vivo qui ont permis la mise en évidence de la sécurité d’emploi ainsi que des propriétés (anti falciformantes, anti-œdémateuses, analgésiques, antipyrétiques, myorelaxantes, vaso-dilatatrices, etc.) liées à la physiopathologie de la maladie. La troisième étape a abouti à la formulation et à la standardisation suite à l’identification de molécules traceurs qui sont des dérivés d’acide vanillique (burkinabines » A, B et C). Des études de validation du procédé de fabrication suivi de stabilité ont été réalisées avant la production et la commercialisation après autorisation de mise sur le marché.
Cette démarche a permis la mise au point d’un phytomédicament qui suscite un grand espoir pour le traitement de la drépanocytose au regard des résultats de l’étude de pharmacovigilance
Bäuerliche Wahrnehmung und Benennung von Gefässpflanzen in der Mossi-Gesellschaft: Eine Fallstudie in den zentralen Regionen Nord-, Nord-Zentral- und Zentral und Zentralplateau in Burkina Faso (Westafrika)
No full textCette étude analyse les stratégies locales de dénomination des espèces végétales par les Mossé des régions du nord, du centre nord, du centre et du Plateau Central du Burkina Faso et leurs perceptions des plantes. A travers des interviews semi directes auprès de 1437 personnes âgées d’au moins 60 ans et des jeunes de moins de 40 ans des différentes localités, l’étude a pu montrer les critères de dénomination, les conceptions que les populations ont des espèces végétales ainsi que l‘impact de ces connaissances dans la conservation de la phytodiversité. 72 espèces au total ont été décrites. Elles sont réparties en 51 genres et 29 familles. Les familles dominantes sont les Commelinaceae et les Fabaceae-Mimosoideae. Dans la taxonomie locale faite sur les plantes en milieu rural Mossé, 16 critères sont utilisés. Les critères les plus cités par la population sont l’usage fait de la plante (94 %), le mysticisme lié à l’espèce (86 %), l’écologie ou le milieu de vie de l’espèce (83 %), la dualité mâle/femelle (83 %), la couleur des organes ou parties de la plante (81 %), l’origine de la plante (80 %), la morphologie foliaire (76 %), la présence d’organes saillants sur la plante (75 %) et le mode de dissémination des fruits ou des graines (74 %). Les noms botaniques attribués aux plantes varient d’une région à une autre. Les populations ont des perceptions vis-à-vis de nombreuses espèces. Ainsi, les espèces comme Stereospermum kunthianum, Calotropis procera, Ozoroa insignis, Faidherbia albida, Maytenus senegalensis et Biophytum umbraculum sont frappées de mysticisme. Elles sont toutes craintes par les populations et sont dans certaines localités à l’abri d’exploitations multiformes humaines. Cela contribue à une meilleure conservation de la biodiversité.This study analyzes local strategies for naming plants by the Mossé of North, North-central, Central and Plateau Central regions in Burkina Faso and their perceptions of the plants. Through semi-structured interviews with 1437 people aged at least 60 years and young people under 40 of different localities, the study has allowed to show the naming criteria, the conceptions that populations have of plant species and the impact of this knowledge in the conservation of plant diversity. 72 species in total were described, belonging to 51 genera and 29 families. The most dominant families are Commelinaceae and Fabaceae-Mimosoideae. In the local taxonomy of plants in Mossé rural areas, 16 criteria are used. The most cited criteria are the use of the plant (94%), the mysticism related to the species (86%), the ecology or the living environment of the species (83%), male/female duality (83%), color of organs or parts of the plant (81%), plant origin (80%), leaf morphology (76%), the presence of prominent organs on the plant (75%) and the mode of dissemination of fruits or seeds (74%). The botanical names vary from one region to another. People have perceptions of many species. Thus, species such as Stereospermum kunthianum, Calotropis procera, Ozoroa insignis, Faidherbia albida, Maytenus senegalensis and Biophytum umbraculum are mystical. They are all feared by the local people and are in certain localities exempt from multiform human exploitation. This contributes to a better conservation of biodiversity.Diese Studie analysiert die Wahrnehmung und lokale Strategien für die Benennung von Pflanzen durch die Mossi der Nord-, Nord-Zentral-, Zentral- und Zentral- und Zentralregion in Burkina Faso. Durch semi-strukturierte Interviews mit 1437 Personen im Alter von mindestens 60 Jahren und Jugendlichen unter 40 Jahren an verschiedenen Orten konnte die Studie die Benennungskriterien, die Vorstellungen von Pflanzenarten und die Auswirkungen dieses Wissens auf die Erhaltung der Pflanzenvielfalt zeigen. Insgesamt wurden 72 Arten aus 51 Gattungen und 29 Familien erfasst, wobei Commelinaceae und Fabaceae-Mimosoideae die dominantesten Familien sind. In der lokalen Taxonomie von Pflanzen werden in ländlichen Gebieten von den Mossi 16 Kriterien verwendet. Die am häufigsten genannten Kriterien sind: Verwendung (94 %), mit der Art verbundene Mystik (86 %), Ökologie oder das Lebensraum (83 %), Dualität männlich/weiblich (83 %), Farbe von Organen oder Teilen (81 %), Herkunft (80%), Blattmorphologie (76 %), Vorhandensein prominenter Organe (75 %) und Verbreitung von Früchten oder Samen (74 %). Die botanischen Namen variieren von Region zu Region. Die Menschen nehmen die Arten unter diversen Aspekten wahr. Beispielsweise sind Stereospermum kunthianum, Calotropis procera, Ozoroa insignis, Faidherbia albida, Maytenus senegalensis und Biophytum umbraculum mystisch. Sie alle werden von der lokalen Bevölkerung gefürchtet und daher zumindest an bestimmten Orten von jeglicher Nutzung ausgenommen, was für die Erhaltung der Biodiversität förderlich ist
Self-medication under uncertainty: Insights on drug quality and consumer behavior in Burkina Faso
No full textDo consumers change their self-medication practices when drug quality changes? We present experimental evidence on this question in the context of Burkina Faso, where self-medication with antibiotics is a prevalent practise. We conduct chemical quality testing of antibiotics and find that one in three products on the market is substandard or counterfeit, exposing consumers to significant risk and uncertainty. Survey data and experiments show that consumers are aware of the risk posed by substandard antibiotics. However, they are not sufficiently able to judge quality based on visual cues and market information. Our experimental data suggest that self-medication increases as drug quality becomes more certain. The results suggest that measures to improve drug quality in the market might be accompanied by increased self-medication.Ändern Konsumenten ihre Selbstmedikationspraktiken, wenn sich die Arzneimittelqualität ändert? Wir präsentieren experimentelle Evidenz zu dieser Frage im Kontext von Burkina Faso - einem Kontext in dem die Selbstmedikation mit Antibiotika eine weit verbreitete Praxis ist. Wir führen chemische Qualitätstests von Antibiotika durch und stellen fest, dass jedes dritte Produkt auf dem Markt minderwertig oder gefälscht ist. Konsumenten sind daher einem erheblichen Risiko und großer Unsicherheit ausgesetzt. Umfragedaten und Experimente zeigen, dass sich die Verbraucher des Risikos bewusst sind, das von minderwertigen Antibiotika ausgeht. Sie sind jedoch nicht ausreichend in der Lage, die Qualität anhand von visuellen Hinweisen und Marktinformationen zu beurteilen. Unsere experimentellen Daten deuten darauf hin, dass die Selbstmedikation zunimmt, wenn die Arzneimittelqualität sicherer wird. Die Ergebnisse suggerieren, dass Maßnahmen zur Verbesserung der Arzneimittelqualität auf dem Markt mit einem Anstieg der Selbstmedikation einhergehen könnten
COMPARATIVE ASSESSMENT OF THE QUALITY OF PARKIA BIGLOBOSA TRUNK BARK POWDERS JACQ. BENTH (FABACEAE-MIMOSOIDEAE) INTENDED FOR THE PHARMACEUTICAL PRODUCTION OF PHYTO-DRUGS
No full textObjective: This study was conducted to determine the physicochemical characteristics and organic and inorganic contaminants of Parkia biglobosa trunk bark powders collected in four localities (Gonse, Yako, Bobo and Nobere) of Burkina Faso.
Methods: The parameters studied were the physicochemical characters, the contents of heavy metals, pesticides and the microbial quality according to the methods of the European Pharmacopoeia.
Results: The study of these parameters revealed a residual moisture content of less than 10% and a uniform pH, macroscopical character and particle sizes for all raw materials. Total ash ranged from 0.09 to 0.96 for powders from Yako and Bobo, respectively. Contaminant assessment revealed that Parkia biglobosa trunk bark contains high levels of manganese (Mn) and lead (Pb). The microbial analysis shows that the trunk bark powders from Gonse, Yako and Bobo complied with the specifications of the European Pharmacopoeia.
Conclusion: These quality control studies allowed the correct identification, characterization and determination of the appropriate harvesting sites for pharmaceutical production of phytomedicine
Evaluation of toxicity, antispasmodic, and analgesic activities of Improved Traditional Medicine (ITM) based on Diospyros mespiliformis and Combretum micranthum indicated in the treatment of gastrointestinal disorders
No full textThis study focused on an improved traditional herbal medicine (ITHM) used in capsule form for the treatment of gastrointestinal disorders. This study aimed to investigate the phytochemistry, toxicity, and pharmacological activity of the ITM. ITM and extracts underwent phytochemical characterization tests and their dosages. Antioxidant, antispasmodic and analgesic properties and acute toxicity study were realized. Bioactive compounds, including flavonoids, saponins, tannins, etc. were detected. The total phenolic of the ITM were higher with 109.02±0.15 mg EAT/g. The highest total flavonoid content was obtained by the decocted with 17.04±0.25 mg EQ/g and ITM with 16.91± 0.80 mg EQ/g. ITM had the best antioxidant activity by the DPPH method with an IC50 of 24.65 ± 1.05 µg/ml; the decocted had the best activity by the ABTS method with an IC50 of 12.86 ± 0.95 µg/ml and the extracts and ITM had significantly the same activities by LPO method, hence the choice of ITM for the rest of the pharmacological activity. ITM has a low toxicity and an estimated LD50 of 5000 mg/kg. The maximum antispasmodic effect of ITM at the maximum concentration of 3.98 mg/mL was 87.30% with an effective concentration 50 (EC50) of 0.66±0.05 mg/mL. The analgesic effect of ITM was dose-dependent, with inhibition percentages at the dose of 50 mg/kg of 59.82%, that of 100 mg/kg of 64.73% and that of 150 mg/kg of 71.43%. The results on ITM provide a scientific basis for its use in the management of gastric pathologies.
Keywords: ITM; Phytochemicals; Antioxidants; Acute toxicity; Antispasmodic; Analgesic
Toxicity assessment of a phytomedicine based on an almond extract from the fruit of Balanites aegyptiaca (L.) DELILE (Zygophyllaceae) intended for helminthiases care in Burkina Faso
No full textBalanites aegyptiaca (L.) Delile (Zygophyllaceae) is a medicinal plant used in traditional medicine in Burkina Faso to treat helminthiasis. Using an ethnopharmacological approach, the "Institut de Recherche en Sciences de la Santé (IRSS)" has developed a phytomedicine based on an almond extract from the fruit of this plant for the treatment of helminthiasis. This study aimed to assess the acute and subacute oral toxicity and in vivo mutagenicity of phytomedicine. The acute toxicity study was carried out following OECD guideline 423 by administering a single dose of 2000 mg/kg body weight (bw) of phytomedicine orally to female mice. For subacute toxicity, OECD guideline 407 was used. Four batches of 10 rats (5 males and 5 females) were used, including a control batch and three treated batches receiving a daily oral administration of the phytomedicine at doses of 250, 500, or 1000 mg/kg bw for 28 days. The mutagenicity test was performed according to OECD guideline 474; five batches of 10 mice (5 males and 5 females) were given oral doses of 500, 1000 or 2000 mg/kg bw of phytomedicine, colchicine as a positive control at 5mg/kg bw and distilled water as a negative control. In the acute toxicity test, the LD50 was estimated at 5000 mg/kg bw. The subacute toxicity study showed no mortality or signs of toxicity in rats. Biochemical analysis revealed no significant differences between control rats and those treated with the phytomedicine for glucose, creatinine, total cholesterol, triglycerides, AST, chlorine, calcium, and potassium. On the other hand, serum levels of ALT, total protein, PO43-, and Na+ were significantly reduced in some treated rats. The mutagenicity test showed no change in micronucleus frequency between treated and control mice. This study showed that phytomedicine based on an extract of B. aegyptiaca fines would present less danger to users.
Keywords: Balanites aegyptiaca, acute toxicity, subacute toxicity, micronucleated erythrocytes, phytomedicine
FORMULATION AND CHARACTERIZATION OF EFFERVESCENT TABLETS FROM A TRADITIONAL MEDICINE RECIPE FOR DENTAL CARE
No full textObjective: Plant use to treat pathologies is increasingly common in Africa. Our study focuses on a recipe (active ingredient) of traditional medicine that has proven itself in treating dental caries and oral pathologies. This study aims to formulate and evaluate the quality of effervescent tablets based on the recipe (active ingredient) for treating dental caries and oral hygiene.
Methods: A physicochemical and pharmacotechnical characterization of the recipe (RMC, pH, Hausner index, Carr index, flow rate) was carried out. Five stoichiometric ratios of the citric acid/sodium bicarbonate combination were used (1:3.32; 1:3.11; 1:3; 1:2.93; 1:2.87). The tablets were obtained after wet granulation. Pharmacotechnical tests were carried out according to the European Pharmacopoeia 10th Ed to determine the most optimal formulation that could promote rapid release of the active ingredient.
Results: The recipe constituting the active ingredient has properties with an apparent density of 0.50, and a density after tamping of 0.65. The compressibility index is 23.61, and the Hausner index is 1.30. These fairly weak rheological properties required improvement through granulation. A total of 5 formulations were obtained. Formulations F2 to F5 had a disintegration time of less than 5 min. The friability rate was less than 4.60%, 0.86%, 0.91%, 0.75%, and 1.22 for the formulations respectively F1 to F5 and the hardness 95N, 81.8N, 118N, 103.6N, 89.8N. The stoichiometric ratio of 1:3.11 gave us the most optimal formulation with a disintegration time of 156 seconds, a friability rate of 0.86%, and a pH of 5.13.
Conclusion: These results demonstrate the feasibility of a solid form to be redispersed for use in oral hygiene
Acute and Subacute Oral Toxicity Studies and Anti-Sickling Activity Assessment of FACA® Syrup
No full textSickle cell disease remains a major public health problem in Burkina Faso and Africa. For the management of this pathology in young children, the Institute for Research in Health Sciences has developed an herbal drug called FACA® syrup. The objective of this study was to verify the safety and pharmacological efficacy of this formulation for its use in the management of sickle cell disease. Acute and subacute oral toxicity tests were performed on Wistar rats in accordance with Organization for Economic Cooperation and Development test guidelines and anti-sickling activity of FACA® syrup was evaluated according to the Emmel test. In the acute test, FACA® syrup didn’t cause mortality or any behavioral change at dose of 2000 mg/kg/b.w suggesting that the test product estimated LD50 is 5000 mg/kg b.w. The results of subacute toxicity study indicate that the daily administration of FACA® syrup during 28 days did not result in significant change on physical, haematological and biochemical parameters up to dose of 1000 mg/kg b.w. The evaluation of effect of FACA® syrup in vitro on sickling revealed that, FACA® syrup possesses a real antisickling activity. Regarding these results FACA® syrup would be considered as safe in both acute and subacute exposure and could be used in the management of sickle cell diseases.
Keywords: FACA® syrup, oral toxicity, sickle cell anemia, Antisickling activit
Capsule Formulation Essay of Herbal Extracts of Trunk Bark of Anogeissus leiocarpus (DC) Guill. Et Perr. (Combretaceae) for the Treatment of Hypertension
No full textIntroduction: The trunks barks of Anogeissus leiocarpus contains multiple antihypertensive components and are, therefore, widely used for the treatment of hypertension.
Objective: This study aimed to formulate capsules containing a freeze-dried aqueous extract of the trunk’s barks.
Methodology: Three (03) capsule formulations were prepared using wet granulation from lyophilised aqueous extract of Anogeissus leiocarpus trunk bark, with different proportions of excipients including Corn starch used as the diluent, Polyvinylpyrrolidone K25 (PVP) used as binding agent and Magnesium stearate used as gliding agents. The filling of capsules was done using a semi-automatic capsule filler with empty capsules of size 3. The flow properties of the granules and the quality control were performed according to the European Pharmacopoeia 10th ed.
Results/Discussion: All granules had good flow properties, and the F1 and F3 formulations had the best pharmaceutics characteristics according to the recommendations of the European Pharmacopoeia 10th ed. The mean levels of phenolic tracers were 0.039±0.0097 mg gallic acid equivalent per capsule (GAE/capsule) for the F1 formulation and 0.059±0.0063 mg GAE/capsule for the F3 formulation.
Conclusion: This study allowed the galenic formulation of capsules based on extracts of good characteristic quality for the treatment of hypertension.
Keywords: Anogeissus leiocarpus, extract, excipients, formulations, capsul
Formulation and development of capsules containing dry extracts from the calyces of Hibiscus sabdariffa L. and the sheaths of Sorghum caudatum H., intended as a dietary supplement
No full textIntroduction: Anthocyanin-rich extracts from Hibiscus sabdariffa L. calyces and Sorghum caudatum H. sheaths are promising antioxidants, but instability and dose variability limit use. This study aimed to standardize and manufacturing capsules containing lyophilized and purified dry extracts with affordable, plant-based excipients.
Methodology: An experimental program (Ouagadougou, Nov 2022–Aug 2023) prepared three extracts, lyophilized H. sabdariffa, purified H. sabdariffa, and purified S. caudatum. Physicochemical and pharmacotechnical tests assessed appearance, pH, hygroscopicity, residual moisture, and powder flow (angle of repose, Carr index, Hausner ratio). Total anthocyanins were quantified by differential pH (H. sabdariffa) and Stonestreet (S. caudatum). Size-0 capsules were formulated with maize starch and, when needed, colloidal silica; quality control evaluated appearance, mass uniformity (n=20), and disintegration (n=6).
Results: Extracts were acidic (pH 4.4–5.3), had residual moisture <10%, and were hygroscopic. Anthocyanins were 11.33±0.49 mg/g (lyophilized H. sabdariffa), 83.91±0.15 mg/g (purified H. sabdariffa), and 317.77±10.07 mg/g (purified S. caudatum). Flow was fairly good for lyophilized Hibiscus (Hausner 1.25) but poor to extremely poor for purified extracts (1.39–1.64); colloidal silica improved filling. Capsules were cylindrical, smooth, and compliant for mass uniformity; mean disintegration was 2.88–3.91 min.
Discussion: Capsules manufacturing enhanced standardized dose delivery, masked acidity, and limited environmental degradation. Gaps include granulometry, microbiological testing, post-formulation flow testing, and finished-product anthocyanin assay; ICH-aligned stability, dissolution in biorelevant media, and content uniformity are recommended.
Conclusion: Bench-scale standardization and capsules manufacturing yielded reproducible, rapidly disintegrating capsules suitable for supplementation and highlight the value of local botanicals.
Keywords: Hibiscus sabdariffa L., Sorghum caudatum H, anthocyanins, capsule
