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According to current international Good Manufacturing Practice guidelines, ongoing stability testing is required for the market-life of all medicinal licensed products, as part of the Annual Product Quality Review. Taking that into account, samples from one batch a year of the three Policosanol formulations (PPG 5, 10 and 20 mg), stored in Climatic Zone IV conditions, were continuously monitored since 2017, in order to demonstrate stability and quality over their 5-years shelf life. Results showed that these three formulations, packed in polyvinylchloride /aluminium thermo-sealed blisters, fulfilled the specified quality parameters during all the study. Until now, all the assayed batches maintained their values of fatty alcohol content, uniformity of content, disintegration time, color, and microbial content without significant changes with respect to the initial values in all samplings. No evidence of degradation product formation was determined by Gas Chromatography, which is consistent with the fact that no decrease in the fatty alcohol content was observed throughout the study. First included batches, produced in 2017 and stored for five years, showed no evidence of degradation and fulfilled all the specification limits defined in their registration documents. That is consistent with the approved labelled shelf life of these formulations, which had been previously determined by Research and Development studies, before their marketing approval. [ABSTRACT FROM AUTHOR]

A new skin protective cream was recently developed containing the fatty alcohols 1-octacosanol (C28) and 1-triacontanol (30), which present antioxidant and anti-inflammatory properties. As part of the development of this new product, a Gas Chromatographic analytical method was validated. This method was used for the analyses of samples from three batches of the cream, which were submitted to accelerated stability assay during 12 months and to long-term stability assay during 36 months. The cream samples, packed at the rate of 25 g in lithographed aluminum tubes with inner epoxy-phenolic coating and high density polyethylene cap, were placed at 40 ± 2 ºC and 75 ± 5 % relative humidity (accelerated stability), and at 30 ± 2 ºC and 70 ± 5 % relative humidity (long-term stability in climatic Zone IV). The validated analytical method allowed to demonstrate that the fatty alcohols content did not change during all the time in which the samples were analyzed, in both assays.Additionally, it was observed that during all the time, the creams kept their original organoleptic characteristics (semi-solid with a uniform appearance, without lumps or sandy consistency, with a white to light cream color and a characteristic odor), as well as their microbiological content and pH between the Quality Specification defined ranges. The results of the present study support that the cream resist 12 months in conditions of accelerated stability and 36 months when stored at the conditions of the climatic Zone IV. [ABSTRACT FROM AUTHOR]

Nowadays, the pharmaceutical regulatory entities are paying special attention to the topic of the residual solvents in the active ingredients (AI). D-004 is a new AI obtained from the Cuban royal palm (Roystonea regia) fruits, which has been shown to be effective in experimental models of prostate hyperplasia. Taking into account the use of n-hexane for obtaining this AI, a new limit test method, based on Static Headspace/GC-MS (SHS/GC-MS), was developed and validated for determining this residual solvent. six batches of D004 were used. For preparing samples, 1 mL of D-004 was placed into 10 mL vial and heated at 80 oC for 1 hour. Afterwards, 1 mL of the head space was immediately injected into the GC-MS. The n-hexane concentrations were determined by interpolating the n-hexane average responses in the calibration curve of the linearity test and limit concentration was established at 60 ppm. The proposed method for determining n-hexane as residual solvent in D004 AI was found suitable sensitive, specific, linear (correlation coefficient≥ 0.999 and R.S.D. of slope ≤ 2.4 %) and precise (RSD ≤ 8 %). Concentrations between 1.6 and 52 ppm were determined with a detection limit of 0.26 ppm. The validated limit test method allowed determining residual n-hexane concentrations, which were < 60 ppm, values that were lower than that established by the ICH (290 ppm). The method was found suitable for quality control of residual n-hexane in D004 AI. [ABSTRACT FROM AUTHOR]

Purslane (Portulaca oleracea L.) contains polyunsaturated fatty acids (FAs) and shows antiinflammatory, antioxidant, immunomodulatory, hypolipidemic and hypoglycemic effects, which are partly attributed to its lipid composition. Although this plant is quite abundant in Cuba, it is not usually consumed and It is any chemical study has not been informed yet. Taking into account these facts, the aim of this work was to study the FAs content of the aerial parts of purslane growing in our country. Aerial parts (leaves and stems) were collected, dried, milled in a mortar and extracted with hexane in an ultrasonic bath during 1 h. The extract was filtered and the solvent evaporated under reduced pressure in a rotary evaporator at 60 °C. A dark greenish brown liquid of oily appearance and characteristic odor was obtained with 1.7 % of yield. Samples were analyzed by gas chromatography and the FAs (1.32 % of fresh aerial parts) were determined as methyl ester derivatives. Majorities FAs were linolenic (37.83 %), palmitic (23.11 %), linoleic (14.42 %) and oleic (6.72 %), while other acids were detected in minor proportions; some of them (caprilic, capric, lauric, pentadecanoic, heptacosanoic, octacosanoic, octadecatetraenoic, gondoic and eicosatetraenoic acids) not previously detected in this species. The present study contributes to the of knowledge chemical composition of aerial parts of Portulaca oleracea L. growing in Cuba, informing the FAs content of its lipid extract. [ABSTRACT FROM AUTHOR]

The oil extracted from the whole fruits of Cuban royal palm (Roystonea regia) could be used in the food or pharmaceutical industry for obtaining a new active ingredient; then, this study investigates the physicochemical characteristics and stability of this oil. Fatty acids composition was determined by gas chromatography and the other determinations by USP 27 official methods. Stability study was assessed in glass containers with rubber cap and aluminum seal, under climatic zone IV conditions (30 ± 2 ºC and 70 ± 5 % relative humidity) over two years. Relative density was between 0.874 and 0.970 g/mL, refractive index between 1.454 and 1.463, saponification value between 190.0 and 221.8, acid value between 5.2 and 26.4, iodine value between 47.8 and 55.8, and unsaponifiable matter content between 2.0 and 13.4 %. The fatty acids content was between 74.4 and 91.3 %. No significant variations were observed in physic, chemical and microbiological characteristics of the three oil batches studied over two years. In conclusion, some of the physical and chemical characteristics of the oil from R. regia whole fruits were determined. This oil is stable over two years in clear glass bottle with rubber cap and aluminum seal under climatic zone IV conditions. [ABSTRACT FROM AUTHOR]

D-004 is a new active ingredient obtained from the Cuban royal palm (Roystonea regia) fruits. This substance is mainly composed by a mixture of saturated and unsaturated free fatty acids, from 8 to 18 carbon atoms, and has shown to be effective in experimental model of prostate hyperplasia. A capillary gas chromatographic method for the determination of the fatty acids in D-004 was developed and validated. The acids were analyzed as methyl ester derivatives, which were obtained by reaction with 10 % acetyl chloride in methanol and separated in a BPX-5 wide-bore column using tridecanoic acid as internal standard. The specificity study showed no interferences regarding the determination of this mixture, once the samples were submitted to stress conditions. Determination of the total fatty acid content was linear (r > 0.999; CVs of the response factors and of the slopes lower than 5 and 2 %, respectively) and without bias in the studied concentration range, from 50 to 150 % of the nominal mass. In the accuracy study, over the range 80 to 120 % of the nominal fatty acid concentration, high recoveries (100.4 to 100.8 %) were reached. Good results were obtained in the repeatability and intermediate precision studies (CV < 2 %), proving that the method is precise. These results support that this method is properly validated, being appropriate for the quality control and stability studies of this active ingredient. [ABSTRACT FROM AUTHOR]

Se presentan los resultados de un estudio de la estabilidad química y microbiológica de aceite obtenido de la fruta de Roystonea regia (palma real cubana). Se determinaron los contenidos de AG (ácidos grasos) a partir de un método analítico por cromatografía de gases. Los resultados indican una estabilidad de al menos dos años.