Production of Directly Compressible Excipients With Mannitol by Wet Granulation: Rheological, Compressibility and Compactibility Characterization

Abstract

The purpose of this research was to produce co-processed excipients using mannitol as base material with some of the most used binders: potato, maize pre-gelatinized starch, and K-25, K-29/32, K-90 povidone. Mannitol, one commercial basedmannitol product, and the produced materials were characterized by their particle size distribution, Carr's index, Hausner ratio, angle of repose, powder flow, and moisture content. Heckel analysis, compactibility profiles, and Ryshkewitch-Duckworth analysis were also evaluated. It is concluded that co-processing mannitol enhances flow, compressibility, and compactibility properties of the materials. Heckel analysis showed a decreased yield pressure (Py) value for the co-processed materials; while a 10-times increment in mechanical resistance of co-processed materials was observed in compactibility profiles in comparison with mannitol tablets. Ryshkewitch-Duckworth analysis allowed the calculation of the bonding capacity, which in some cases was similar to ductile materials as microcrystalline cellulose. RezumatScopul acestei lucrări a fost obținerea de excipienți co-procesați pornind de la manitol, alături de lianți precum: cartof, poromb, amidon pre-gelatinizat și povidonă K-25, K-29/32, K-90. Manitolul și ceilalți excipienți au fost caracterizați prin distribuția mărimii particulelor, indexul Carr, raportul Hausner, capacitatea de curgere și umiditatea relativă. Analiza Heckel, pofilele de compactibilitate și analiza Ryshkewitch-Duckworth au fost, de asemenea, evaluate. Co-procesarea manitolului îmbunătățește profilele de curgere, compresibilitate și compactibilitate ale materialelor. Analiza Heckel a arătat o scădere a valorii presiuni (Py) pentru materialele co-procesate; a fost observată o creștere de 10 ori a rezistenței mecanice pentru materialele co-procesate pe baza pofilelor de compactibilitate raportate la comprimatele cu manitol. Analiza Ryshkewitch-Duckworth a permis calcularea capacității de legare, care în unele cazuri a fost similară cu cea a celulozei microcristaline.

Development and Evaluation of Hydrophilic Cream Bases Suitable for Custom Cosmetic Skincare or Compounding Pharmaceutical Dermal Products

“…Measurements were performed in continuous and oscillatory flow conditions using a rotational rheometer, Rheotest RV 2.1 (RHEOTEST Medingen GmbH, Germany), at a controlled temperature of 23 ± 0.05°C. Flow curves were obtained representing the shear rate -D (s -1 ) against shear stress - (dynecm -2 ) [31][32][33][34][35]. The size of hysteresis (H) was expressed in terms of hysteresis area, by the difference between AUC_d (area under the flow curve during the destructuring of the emulsified system, when the shear rate was increased) and AUC_r (area under the flow curve during restructuring, when the shear rate was decreased).…”

“…The tolerance assessment was performed on subjects aged 18 -70 years, Fitzpatrick II -IV phototype, and the evaluation of hydration efficiency on subjects aged 50 to 65 years, phototype Fitzpatrick III. The specific inclusion criteria were: very dry skin on the inside of the forearm, without excessive hair, pigmentation disorders, scars, sunburn, nevi, and freckles in the experimental area [34]. The specific criteria for non-inclusion were: family or personal history of atopic skin.…”

Diseño de estudios Gauge R&R cruzado y anidado para la validación de los modelos matemáticos de Heckel y Ryshkewitch-Duckworth

“…(14) En la literatura, existen pocos reportes sobre la aplicación de dichos estudios en el sector farmacéutico y a pesar del gran campo de aplicación, los estudios se enfocan al estudio de la variabilidad de la disolución, desintegración, dureza de tabletas con geometría pentagonal y variación en el análisis de valoración de principios activos. (15)(16)(17)(18)(19) Como herramienta, los estudios gauge ayudan a ganar información sobre el desempeño de los procesos y resultan de gran utilidad en áreas como el control de calidad para el aislamiento de productos defectuosos en sistemas de manufactura; anteriormente, miembros de este grupo de investigación usaron estudios gauge para la validación de modelos matemáticos para el estudio de la compresibilidad y compactabilidad; (20) sin embargo, se destaca que a la fecha no existen reportes en la literatura sobre el uso de los estudios gauge para dicha finalidad, por lo que el objetivo del presente estudio es el de diseñar y analizar los sistemas de medición para la caracterización de los materiales con los modelos de Heckel y Ryshkewitch-Duckworth de comprimidos de distintos materiales a través de un estudio Gauge R&R cruzado para la evaluación del peso y un estudio Gauge R&R anidado para la resistencia a la fractura de los comprimidos. Mediante dichos estudios, se determinará si los investigadores (referidos como Operadores en la literatura) o las diferencias en las propiedades de los materiales constituyen la principal fuente de variación en un estudio y por tanto en los modelos matemáticos previamente indicados.…”