Mirna Fernández

Evaluation of Chitosan Acid Salts as Clarifying Agents of Orange Nectar

The use of chitosan acid salts was assessed in the clarification orange nectar. Clarification process was performed at laboratory scale by the classical methodology of jar test by adding chitosan acetate or chitosan lactate at concentrations between 0 g/L and 2 g/L of nectar. Numerical optimization method was used through an IV Optimal response surface for the best variant of coagulation-flocculation based on clarification yield. No significant effect of the salt type and concentration or clarification time on the physicochemical parameters of nectars were observed. Both chitosan acid salts could be used as clarifying agents, although chitosan lactate at 1 g/L was more effective, obtaining the highest yield (66.14%) to a time of 90 min. In general, there was no significant influence of the type and concentration of chitosan acid salt on the sensory attributes of the products and nectar clarified with chitosan lactate showed the higher overall quality.

Rapid Development and Optimization of Tablet Manufacturing Using Statistical Tools

The purpose of this paper was to develop a statistical methodology to optimize tablet manufacturing considering drug chemical and physical properties applying a crossed experimental design. The assessed model drug was dried ferrous sulphate and the variables were the hardness and the relative proportions of three excipients, binder, filler and disintegrant. Granule properties were modeled as a function of excipient proportions and tablet parameters were defined by the excipient proportion and hardness. The desirability function was applied to achieve optimal values for excipient proportions and hardness. In conclusion, crossed experimental design using hardness as the only process variable is an efficient strategy to quickly determine the optimal design process for tablet manufacturing. This method can be applied for any tablet manufacturing method.

Stability of spray-dried chitosan salts derived from lobster chitin as a raw material

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.

Desempeño del método cromatográfico para el estudio de estabilidad del aceite de hígado de tiburón microencapsulado empleando acetato de quitosana

Purpose: To evaluate the performance of the method for the quantification of vitamin A in the microencapsulated oil using chitosan acetate and maltodextrin as encapsulating agents, and to study the stability of microencapsulated oil. Materials and methods: The evaluated parameters were in accordance with international standards among those that we can mention: specificity, accuracy and precision. The stability study was carried out for 12 months at room temperature (30 ± 2 ° C) and 70 ± 5% relative humidity, the following parameters were evaluated: capsulation efficiency, loss on drying, superficial oil, vitamin-A content and microbiological count. Results: It was demonstrated that the evaluated method was specific, precise and accurate for the determination of vitamin A in the microencapsulated oil. The results demonstrate that the microencapsulated oil has a stable behavior in terms of evaluated parameters, showing the protection provided by the components of the wall material. Conclusions: The method used in the quantification of vitamin A in the microencapsulated oil was specific, accurate and precise, for what can be an employee in the quality control and stability study. The microencapsulated oil with chitosan acetate and maltodextrin as encapsulating agents turned out to be physically, chemically and microbiologically stable for a period of 12 months.

AB0773 The Treatment with Denosumab plus Biologic Dmards in Patients with Rheumatic Chronic Diseases Showed Efficacy and Safety. A Case Series

Background The T2T strategy of treatment in severe inflammatory rheumatic diseases includes the use of biologic DMARDs (bDMARDs). However, the combination of two or more bDMARDs is not recommended due to toxicity, mainly infections. These patients had high risk of osteoporosis (OP) and its treatment is at least as important as the rheumatic disease. For this, the use of the combination of denosumab (DNS) plus bDMARD is increasing. Objectives To know the prevalence of patients in treatment with DNS + bDMARD. To describe the inflammatory rheumatic disease and the OP. To know the frequency of severe adverse events of the combination. Methods Design: An observational, retrospective, case series in common clinical practice. Methods: Nine rheumatologists were trained about design, protocol and data management. They reviewed all the clinical charts of patients with bDMARDs and identified those with at least one prescription of DNS. Of each case 53 variables were filled in a database, and the database was re-reviewed in order to verify the data. The statistical analysis was done with descriptive statistic. The incidence density rate for adverse events was calculated. Results 1,540 clinical charts were reviewed (569 of the HUVM and 971 of the HUVR), 38 cases of patients with DNS+bDMARD were found. The prevalence was 2.46%. They were female (36, 95%), with RA (28, 74%), SLE (2, 5%), and APs (2, 5%) and others. The mean (p25-p75) age at the rheumatic disease diagnostic was 49 (35–62) years old; the mean age at the OP diagnostic was 61 (54 - 68). The bDMARD were ETN (16, 42%), RTX (9, 24%), ADA (4, 10%), INF (3, 8%), ABA (3, 8%), TCZ (2, 5%) y GOLI (1, 3%) and the duration of the bDMARD treatment was of 60 (25–120) months. In addition, the most common synthetic DMARD used was MTX in 15 (40%) cases, and the dose was 15 mg/week (7.5 – 20). In 26 (67%) cases corticosteroids were used and the dose was 5 mg/day (5–10). Most of them had a mixed OP (glucocorticoid related and postmenopausal), n=26, 72% and in 5 cases the OP was postmenopausal. Fragility fractures (FF) previous to DNS were found in 9 cases (23%). The FF were peripheral (5, 13%); 2 (5%) vertebral FF and 2 (5%) with both of them. The patients received a mean of 3 (2–6) doses of DNS, with a duration of DNS treatment of 14.7 (6 – 37.9) months. The baseline FRAX score calculated without BMD for major osteoporotic FF was 13 (5.6 – 31) and for hip FF was 3.8 (0.7 – 16). The BMD showed T-score of femoral neck of -2.5 (-1.3 - -3.1) and total lumbar of -2.4 (-1 - -3.5). There were three cases of incident FF (5.07 FF x 100 patient/year). The adverse events were three urinary tract infections, and one of soft tissue. The infections were mild and treated with PO antibiotics. The rate was 6,75x 100 patients/year. There were not severe infections, admissions to the emergency room, neither deaths. Conclusions The frequency of the combination of DNS + bDMARD is low. This combination is used in patients with inflammatory rheumatic disease of a major length, damage and long treatment with steroids. The efficacy of DNS was the expected with no increased in toxicity. Disclosure of Interest None declared