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De La Paz N.,Research Center sarrollo Of Medicamentos Cidem | Garcia C.,Research Center sarrollo Of Medicamentos Cidem | Fernandez M.,University of Habana | Garcia L.,Research Center sarrollo Of Medicamentos Cidem | And 3 more authors.
Ars Pharmaceutica | Year: 2015

Aim. The objective of this work was to develop and validate a method for determining the degree of molar deacetylation of chitosan acetate and chitosan lactate, as well as to study the stability of both salts. Materials and Methods. A spectrophotometric method was validated according to internationally-established quantitative techniques. Three industrial batches of chitosan acetate and chitosan lactate, obtained by spray drying, were stored under shelf life conditions for twelve months. Organoleptic characteristics, the degree of molar deacetylation, pH, loss on drying and microbiological count were determined at the beginning and end of the study. Results and Discussion. The statistical data proved that the two methods complied with international standards for the validation of analytical techniques. It was shown that the procedures developed were linear, specific, precise and accurate, so they can be used for the purposes of quality control and stability study of the polymer salts. Salts remained in powder form, with a light-yellow to dark-yellow coloration. Values of loss on drying (2.5 - 5.2 %) of chitosan salt using acetic or lactic acid, as a solvent, indicated the good quality of spray-dried particles of chitosan. Similar behavior was obtained regarding pH. The two salts stayed within the parameters that determine their quality, both in the initial stage and after twelve months at room temperature. Conclusion: Spray drying chitosan acetate and chitosan lactate, stored at room temperature in a dry place, in double polyethylene bags and multilayer paper bags, kept their physical, chemical and microbiological characteristics for a period of twelve months.

Perera L.M.S.,Pharmacology and Toxicology Group | Escobar A.,Pharmacology and Toxicology Group | Souccar C.,Product Natural Sector | Antonia Remigio M.,CIDEM Inc | Mancebo B.,Pharmacology and Toxicology Group
Journal of Pharmacognosy and Phytotherapy | Year: 2010

Rhizophora mangle L. is a vegetal species widely distributed in Cuba and other Caribbean countries. This species is characterized by several ethnobotanical activities as antiseptic, astringent, as well for treating skin ulcers. In the present work, we describe a pharmacological, toxicological and chemical evaluation of this plant by its use in human medicine for the treatment of gastroduodenal ulcers. The acute gastric ulcer's models were: acute gastric ulcers induced by ethanol; indomethacin; pyloric ligation; stress and immobility in cool in mice. The antisecretor effect of the extract was evaluated by pyloric ligation model. Other pharmacological tests were planned with the freeze - dried extract of R. mangle, as part of the evaluation on other systems to known secondary or adverse effects. These tests included the activity of the antiulcer active extract on intestinal transit, activity over arterial pressure, ileum activity and absorption of glucose in gut. The chemical profile of this extract by fatty acids was studied by Gas Chromatography/Mass Spectrometry. Some toxicological studies (genotoxicity) were carried out. The aqueous extract of R. mangle bark showed gastroprotective, antisecretor effects, and it induced a recovery of PGE2 levels in doses-dependence manner comparable of knowledge antiulcerogenic medicaments. No effect was observed by arterial pressure in rats and the intestinal transit was inhibited by R. mangle. The intestinal motility was stimulated. Antiulcer active extract inhibit the glucose absoprtion in gut. This extract presented 4% of saturated and not saturated long chain's fatty acids (C10:0 at C24:0). No toxicological signs were obtained by this extract. © 2010 Academic Journals.

Hernandez O.D.L.,Research Center sarrollo Of Medicamentos Cidem | Alvarez L.O.M.,CIDEM Inc
Revista Cubana de Plantas Medicinales | Year: 2010

INTRODUCTION: to obtain extracts and juices of vegetal origin as powders, it is necessary to use the spray drying because this method preserves the natural compounds present in these products. Compounds like sugars prevent them from being spray dried without sticking to the inner surfaces of the dryer, all of which results in poor product recovery. The use of inert additives as soluble starch, cellulose or maltodextrin, favors the product recovery by increasing the glass transition temperature. OBJECTIVES: to use design tools for plant extract spray drying process. METHODS: the glass transition temperature was estimated for different extracts by differential scanning calorimetry. Sticking temperature as well as individual drying indexes were calculated. RESULTS: it was demonstrated that the use of additives in plant extract spray drying processes allows obtaining powdered extracts when it is not possible to dry the extract alone. This methodology can be applied to various extracts. CONCLUSIONS: the feasibility of the submitted methodology as a tool for defining adjuvant concentration and drying temperatures was shown.

Parraa A.L.,CIDEM Inc | Rodriguez J.C.G.,National Center for Laboratory Animal Breeding
Central Nervous System Agents in Medicinal Chemistry | Year: 2012

The most common cause of stroke is cerebral ischemia, where blood flow to the brain is interrupted due to a thrombus in a major cerebral artery. Currently, the only therapeutic approach available is thrombolysis. A more recent approach that has started to gain attention is neuroprotection, the ability to prevent neuronal death and enhance endogenous protective mechanisms. Several studies have shown the neuroprotective action of Erythropoietin (EPO). A potential problem in the use of EPO for neurodegenerative disorders is the undesirable erythropoietic side effects. In this context, investigations have been focused to develop derivatives of EPO lacking erythropoietic activity but retaining neuroprotective potential. Low sialic acid-containing EPO (Neuro EPO) is very similar to the one that occurs in the mammalian brain and is rapidly degraded by the liver. Similar neuroprotective effects had been observed with neuro EPO, original recombinant human EPO and EPO variants in ischemia models. Intranasal route could be safe and hematological side effects could be avoided. Neuro EPO that constitutes a new agent has retained the neuroprotective effects without stimulating the EPOR in the bone marrow and can therefore be used without increasing the hematocrit. This review gives a brief introduction to the no hematopoietic effects of EPO, the evidence of neuroprotective effect, the alternatives for obtaining an EPO derivate without hematological side effects and discusses the advantages of nasal administration of Neuro EPO for neuroprotective stroke treatment. © 2012 Bentham Science Publishers.

Perez A.,CIDC | Favier A.,Ecole Polytechnique Federale de Lausanne | Martirena F.,CIDEM Inc | Scrivener K.,Ecole Polytechnique Federale de Lausanne
RILEM Bookseries | Year: 2015

This paper discusses influence of manufacture parameters of a new type of cement (low carbon cement, LC3) which can substitute up to 50% of clinker by calcined clay and limestone. Limestone powder accelerates the early hydration and calcined clays and contributes to strength development at later ages due to its pozzolanic reaction. Further, it facilitates improving rheology of the fresh mix without compromising strength, possibly due to the synergetic interaction between calcined clays and limestone. Workability of this new system is strongly affected by the Particle Size Distribution (PSD) and PSD is affected by the grinding process, therefore, due to the different hardness and grindability between the materials forming this cement, new production parameters must be defined. This study compares the results obtain by separate grinding and intergrinding, especially the impact at rheology and early strength. The influence of clinker and limestone on both properties has been assessed, aided by microstructural studies using different techniques (XRD, TGA, IC, etc.) to determine the best fineness combination and analyze the effect of PSD of the new system in cement properties. Intergrinding seems to give reasonable good results in terms of rheology and early strength. © RILEM 2015.

Da Fonseca L.M.C.M.,Polytechnic Institute of Porto | Da Fonseca L.M.C.M.,CIDEM Inc | Ferro R.L.,Bureau Veritas
International Journal of Industrial Engineering and Management | Year: 2016

Management and Total Quality Management Theories support the importance of employee satisfaction and customer satisfaction for companies economic results and ensuring success. However, there are still some gaps concerning evidence of relationships between these three constructs. This research aims to access if there are indeed positive relationships between employee satisfaction, customer satisfaction and companies economic performance. By using a large database from a Portuguese Official Agency, framed according to the EFQM Business Excellence Model, with inputs of small and medium companies in stable industries over 10 years, 3 hypotheses were statistically tested. The results support the propositions of valid relationships between EFQM Model results criteria with evidence of positive relationships between employees satisfaction and customer satisfaction and economic performance, and between customers satisfaction and companies economic performance, which is relevant both from a theoretical and practical point of view.

Lagarto A.,CIDEM Inc | Bueno V.,CIDEM Inc | Guerra I.,CIDEM Inc | Valdes O.,CIDEM Inc | And 3 more authors.
Experimental and Toxicologic Pathology | Year: 2011

The use of human recombinant erythropoietin (EPO) as a neuroprotective agent is limited due to its hematological side effects. An erythropoietin along with a low content of sialic acid (rhEPO. b), similar to that produced in the brain during hypoxia, may be used as a neuroprotective agent without risk of thrombotic events. The objective of this investigation was to assess the toxicological potential of a nasal formulation with rhEPO. b in acute, subacute and nasal irritation assays in rats. Healthy Wistar rats (Cenp:Wistar) were used for the assays. In an irritation test, animals received 15μl of rhEPO. b into the right nostril. Rats were sacrificed after 24. h and slides of the nasal mucosa tissues were examined. Control and treated groups showed signs of a minimal irritation consisting of week edema and vascular congestion in all animals. In the acute toxicity test, the dose of 47,143. UI/kg was administered by nasal route. Hematological patterns, body weight, relative organ weight, and organ integrity were not affected by single dosing with rhEPO. b. In the subacute toxicity test, Wistar rats of both sexes received 6,600. UI/kg/day for 14 days. The toxicological endpoints examined included animal body weight, food consumption, hematological and biochemical patterns, selected tissue weights, and histopathological examinations. An increase of lymphocytes was observed in males that was considered to reflect an immune response to treatment. Histopathological examination of organs and tissues did not reveal treatment-induced changes. The administration of rhEPO. b at daily doses of 6,600. UI/kg during 14 days did not produce hematological side effects. These results suggest that rhEPO. b could offer the same neuroprotection as EPO, without hematological side effects. © 2010 Elsevier GmbH.

Lagarto A.,CIDEM Inc | Bueno V.,CIDEM Inc | Guerra I.,CIDEM Inc | Valdes O.,CIDEM Inc | And 2 more authors.
Experimental and Toxicologic Pathology | Year: 2011

We have studied the acute and subchronic oral toxicities of Calendula officinalis extract in male and female Wistar rats. A single acute C. officinalis extract dose of 2000. mg/kg dissolved in distilled water was administered by oral gavage for acute toxicity. Subchronic doses of 50, 250 and 1000. mg/kg/day were administered in drinking water. The major toxicological endpoints examined included animal body weight, water and food intake, selected tissue weights, and histopathological examinations. In addition, we examined blood elements: hematocrit, hemoglobin concentration, erythrocyte count, total and differential leukocyte count and blood clotting time and blood chemistry: glucose, total cholesterol, urea, total proteins, alkaline phosphatase, alanine aminotransferase (ALT) and aspartate aminotransferase (AST). In the acute study, there were no mortality and signs of toxicity. In the subchronic study, several of the blood elements were significantly affected in males and females after 90 days; hemoglobin, erythrocytes, leukocytes and blood clotting time. For blood chemistry parameters, ALT, AST and alkaline phosphatase were affected. Histopathological examination of tissues showed slight abnormalities in hepatic parenchyma that were consistent with biochemical variations observed. These studies indicate that the acute and subchronic toxicities of C. officinalis extract are low. © 2010 Elsevier GmbH.

Lagarto A.,CIDEM Inc | Merino N.,CIDEM Inc | Valdes O.,CIDEM Inc | Dominguez J.,CIDEM Inc | And 3 more authors.
International Journal of Biological Macromolecules | Year: 2015

Chitosan is a natural polymer with excellent properties such as biocompatibility, biodegradability, non-toxicity and adsorptive abilities. We obtained chitosan derived from Panurilus argus lobster shell and its lactate and acetate salts to introduce in pharmaceutical industry. We examined the single and repeated dose toxicity of chitosan and its lactate and acetate salts. Single oral doses of 2000. mg/kg were well tolerated for all three materials. In the repeat dose tests, animals treated with chitosan only show a slight erythrocytes increase. Variations in erythrocyte and leukocyte count and some biochemical parameters were observed in animals treated with chitosan acid salts. One g/kg orally was found to be the subacute NOAEL for chitosan due to the hematological findings observed were not considered adverse. Chitosans obtained from Panurilus argus lobster shell have low toxicity and may be safe in rats because it did not cause any lethality or changes in the general behavior in both the single and repeated dose toxicity studies. © 2014 Elsevier B.V.

Within traditional human knowledge Ethnopharmacology is prominent. In Cuba, around 1170 botanical species have been documented with proven or attributed medicinal properties. In order to determine the patent protection of pharmaceutical products based on Cuban genetic resources, the databases of patents in the Cuban Office of the Industrial Property (OCPI) web site and PATENSCOPE in the World Organization of the Intellectual Property web site were consulted. The genetic resources present in the 45 recovered Cuban patents were identified; of these only 2 are autochthonous. The immense majority of the terrestrial phytogenetic resources are attributable to ethnopharmacological knowledge. Only 7 of the patents have requested foreign registration. The management of patents based on Cuban genetic resources and ethnopharmacological knowledge is poor, in spite of our great genetic wealth, biodiversity and preservation of the cultural traditions in this area. © 2010 Boletín Latinoamericano y del Caribe de Plantas Medicinales y Aromáticas.

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