Marylène Viana

• University of Limoges

La mise sur le marché d’un nouveau médicament fait intervenir des spécialistes de diverses disciplines. Les futurs professionnels de l’industrie pharmaceutique doivent non seulement acquérir des connaissances scientifiques variées afin d’être capables d’intégrer l’ensemble des problématiques, mais ils doivent également développer leurs compétences...

The present work aims to reveal the pharma-industrial benefits of the use of hydrothermally synthesised titanate nanotube (TNT) carriers in the manufacturing of nano-sized active pharmaceutical ingredients (APIs). Based on this purpose, the compressibility and compactibility of various APIs (diltiazem hydrochloride, diclofenac sodium, atenolol and...

Résumé Les formes à libération prolongée ont été développées dans le but de réduire la fréquence des prises médicamenteuses. Lors de la délivrance, le patient doit être informé de la particularité de ces médicaments et de leurs modalités de prise.

Effective treatment of critical-size defects is a key challenge in restorative surgery of bone. The strategy covers the implantation of biocompatible, osteoconductive, bioactive and biodegradable devices which (1) well interact with native tissue, mimic multi-dimensional and hierarchical structure of bone and (2) are able to enhance bone repair, tr...

Bone tissue regeneration with bioceramics-based biomaterial can suffer from associated bone infections. The objective of this study was to develop new antibiotics drug delivery systems, composed of ceramics matrix with a controlled porosity aiming at releasing the antibiotics loaded in the matrix, in the bone implantation site and in a controlled w...

Abstarct Infections after bone reconstructive surgery are a real therapeutic and economic issue for the modern health care system. As the pathogen (most often Staphylococcus aureus) is able to develop a biofilm inside the bone, local delivery of antibiotics is of interest since high drug concentrations would be delivered directly at the target plac...

Les céramiques phosphocalciques (hydroxyapatite, phosphate tricalcique) sont couramment utilisées comme implants synthétiques en substitution osseuse. Le développement de nouveaux implants céramiques aux performances accrues nécessite la maîtrise de nombreux paramètres chimiques et physiques intervenant dans leurs procédés d'élaboration : synthèse...

Drug loaded porous calcium phosphate bone substitutes are studied for targeted drug delivery applications. In this study, porous hydroxyapatite and beta-tricalcium phosphate pellets were investigated as anti-inflammatory drug carriers and their ibuprofen adsorption and release properties were compared. While the adsorption equilibrium time of 1 h w...

Calcium phosphate bone substitute materials can be loaded with active substances for in situ, targeted drug administration. In this study, porous β-TCP pellets were investigated as an anti-inflammatory drug carrier. Porous β-TCP pellets were impregnated with an ethanolic solution of ibuprofen. The effects of contact time and concentration of ibupro...

Single pot mixer-granulator-dryer (high-shear granulator with in situ double jacket vacuum drying) and multiphase equipment (high-shear granulator associated with fluid bed dryer) are classically used for wet granulation. At present time, industrial production imperatives may require to switch one formulation from one equipment to another. To compa...

At present time, industrial production imperatives can require the transposition of a formulation from one equipment to another. In order to evaluate the impact of such a switch on the properties of granules and tablets, investigations were undertaken on formulations manufactured both in a single pot mixer-granulator-dryer (high shear granulator wi...

This paper studies the impact of the location of a drug substance on the physicochemical and mechanical properties of two types of calcium phosphate granules loaded with seven different contents of ibuprofen, ranging from 1.75% to 46%. These implantable agglomerates were produced by either low or high shear granulation. Unloaded Mi-Pro pellets pres...

The use of phosphocalcic bioceramics for medical applications is discussed. Phosphocalcic bioceramics are being increasingly used for such applications, as they are suitable for making implantable systems for the controlled release of active molecules. The most commonly used phosphocalcic bioceramics for these applications include phosphocalcic hyd...

Among the high shear wet granulation equipments used in the pharmaceutical industry, two configurations are current: single pot process for which blending, granulation and drying are performed in the same apparatus and multiphase process that usually associates a mixer granulator and a fluid bed dryer. Pharmaceutical formulations are often develope...

Porous calcium phosphate pellets were produced according to two granulation processes (low and high shear wet granulations) and drug loaded with five ibuprofen contents (1.75%, 7%, 12.5%, 22%, and 36%) in order to ensure both bone defect filling and local drug delivery. The drug-release kinetics from the two types of pellets was studied using three...

Calcium phosphate porous ceramics present a great interest not only as complex bone defect fillers but also as drug delivery systems. Most of the methods described in the literature to fabricate pellets are based on compaction, casting into spherical molds, or on processes such as liquid immiscibility or foaming. Despite wet granulation is used in...

The aim of this study is to limit the hurdles generated by the presence of a surfactant, i.e., sodium dodecyl sulfate (SDS), in effervescent detergent tablets containing a chlorine provider. The results are highlighted by investigating the tablet’s functional characteristics (mechanical strength, disintegration time). A second objective is to incre...

This paper describes the use of a novel flow cell, the T-cell, adapted to the flow-through cell apparatus, for the study of ibuprofen release from implantable loaded pellets and its performance in comparison to the compendial tablet cell. In fact, the drug targeting with a local delivery system becomes increasingly used to achieve therapeutic doses...

Pharmaceutical granulations are usually developed with regard to a specific manufacturing process but switching from one piece of equipment to another can be necessary to comply with the available industrial equipment. Investigations were undertaken on formulations differing in the drug substance and in its concentration. Our aim was to highlight t...

The aim of this study was to highlight the effect of the drying process on granules manufactured in a pilot scale single pot granulator and dried either in situ or in a fluid bed dryer, for formulations differing in drug substance and its concentration (1%; 25%). Although most of raw data were within specifications, single pot drying tended to impr...

The purpose of this study was to develop bioceramics with a well-defined porous structure in order to control drug loading and release over time. Porous structures were obtained through colloidal processing, using polymethyl methacrylate (PMMA) microspheres as templates (core) and hydroxyapatite (HA) nanoparticles as inorganic building blocks (shel...

Spherical porous calcium phosphate pellets were fabricated by high shear wet granulation using native starch as a binder. After a heat treatment to eliminate the organic template, pellets were loaded with ibuprofen by solvent evaporation method. In vitro drug release kinetics was determined using an USP II apparatus (Prolabo Dissolution Tester, Fra...

Wet high shear granulation followed by heat treatment was used to manufacture calcium phosphate porous spherical pellets. Experimental conditions were determined in order to obtain pellets presenting required specifications, i.e. size of about 800 μm, maximum sphericity and high microporosity. These pellets were intended for bone defect filling and...

We have studied the imbibition and dissolution of a porous material in two separate scenarios: (1) when the porous material contains a surfactant powder and (2) when the porous material is dissolved in a surfactant solution. We show that the dissolution kinetics in both scenarios is significantly affected by the presence of the surfactant and resul...

The functional characteristics (mechanical strength, disintegration and dissolution times) of effervescent detergent tablets containing chlorine provider were investigated according to the presence of a surfactant, sodium dodecyl sulphate (SDS). Tablets were compared for similar total porosity. The end-use property study highlighted that the presen...

This paper is a review of solid and casting manufacturing processes able to create porous materials, mainly in the biomaterial field. The considered methods are based on pore forming agents that are removed either by heating or by dissolution. All techniques lead to products presenting pores with amount, size, and shape are close to those of the in...

The thermal response of a ceramic body during firing will be controlled by its thermophysical characteristics. Laser flash measurements have been used to investigate the thermal conductivity of pressed powder compacts of pure tin oxide as a function of temperature. After an initial decrease up to 150°C attributed to removal of surface species, the...

Investigations were carried out to elucidate the compression behavior of a powdered surfactant, sodium dodecyl sulphate (SDS), based on a comparison with the main component of a detergent formulation, i.e. the chorine provider (DCCNa). The energetic analysis based on the compression cycles highlighted a lower compressibility of SDS compared with DC...

As a part of a study on detergent tablets, investigations were carried out to elucidate the compression behavior of a powdered surfactant, sodium dodecyl sulphate (SDS), based on a comparison with the main component of the formulation, i.e. the chorine provider (DCCNa). The compacted SDS exhibited poor cohesion as well as delayed dissolution whatev...

The disintegration of porous tablets, obtained by powder compression, is being studied. Tablets dissolve into a liquid through a two-step process including (i) an imbibition process inside the porous medium and (ii) a dissolution process of the powder aggregates. First, we show that the imbibition process follows the classical laws of capillarity....

The aim of the study was to prepare porous pellets several hundred micrometers in diameter into or onto which drug substances could be embedded. Wet granulation was carried out on a powder mix of alpha-lactose and polyvinylpyrrolidone in a Mi-Pro high-shear granulator. The process parameters were investigated to point out their influence on pellet...

The aim of this study is to investigate the functional characteristics (mechanical strength and disintegration time) of effervescent detergent tablets containing chlorine provider in the presence of surfactant. A preliminary study high-lighted that the presence of 2% of sodium dodecyl sulfate (SDS) was not favorable to the tablet mechanical propert...

High-shear wet granulation is widely used for the production of pharmaceutical dosage forms. Different equipment is available for high-shear granulation and drying. This review focuses on two main processes for granules production: multiphase consisting of high-shear granulation followed by drying in a separate apparatus, and single pot granulation...

The aim of this study is to investigate the functional characteristics (mechanical strength, disintegration and dissolution) of effervescent detergent tablets with chlorine provider under various storage conditions. The contribution of surfactant to the tablet stability was studied by comparing tablets without and with surfactant. After one year of...

Epilepsy is a major public-health problem in Africa. The quality of available drugs is a limiting factor for an adequate management. The aim of this study was to describe the proportion of poor-quality phenobarbital (PB) solid-dosage forms and evaluate the factors associated with its quality in Nouakchott (Mauritania). A cross-sectional study was c...

In most pharmaceutical formulations, the part of the excipients, in quantity and number, is larger than that of active principles, justifying particular attention to their characteristics to ensure quality, efficacy, and reproducibility of final forms. Whereas chemical specifications are described in Pharmacopeias, physical characteristics, up to n...

The chemical nature of tricalcium phosphate used as compression excipient is not well defined. It can vary between β‐tricalcium phosphate (Ca/P molar ratio = 1.50) and hydroxyapatite (Ca/P molar ratio = 1.67). The present study deals with the compression properties of calcium phosphates with different Ca/P molar ratios (1.50, 1.63 and 1.67) and two...

Different apatitic calcium phosphates used as direct compression excipients have been developed in the last years. The difficulty to obtain reproducible synthesis explains their approximative and irregular composition. TRI-TAB® commercial grade called anhydrous tricalcium phosphate is associated to a chemical formula corresponding to a mixture of t...

A method has been developed to analyse the bulk and mechanical properties of powders under pressure using a uniaxial press. This easy-to-use and rapid method requires small amounts of material and allows different compression parameters to be assessed. Classical parameters, e.g. compaction ratio and tensile strength, are determined. The recording o...

Pycnometric density is at the moment the closest approximation of true density calculated from the molecular weight and crystalline lattice of the product. It is determined by using helium pycnometers that offer the advantage of being easy-to-use and rapid, especially fully automated apparatus. If the accuracy and the reproducibility of the techniq...

Three manufacturing processes were applied to two formulations composed of 20% anhydrous theophylline associated with either 20% microcrystalline cellulose and 60% lactose or 80% Cellactose. The processing method (dry blending, grinding, or spray drying) and the formulation were investigated through the comparison of the physical and flow character...

Measurement of the cycles of compression and rupture helps to understand the phenomena occurring during compaction. Different parameters are deduced from the cycles, such as the packing of the material and energies used during compression. The ratio between the energy of rupture and the energy of compaction defines the efficacy of compaction of the...

Literature concerning calcium phosphates in pharmacy exhibits the chemical diversity of the compounds available. Some excipient manufacturers offer hydroxyapatite as a direct compression excipient, but the chemical analysis of this compound usually shows a variability of the composition: the so-called materials can be hydroxyapatite or other calciu...

A parameter, defined by Gabaude et al. in a previous work 1), was further investigated for its ability to evaluate flow properties of particulate materials. It is based on the volume reduction of the powder bed under low compaction pressure. Compaction data and the packing coefficient (Ct=[(H0-Hp)/H0].100) were analysed over a [0-1] MPa pressure ra...

A model mixture of theophylline with two excipients (α-lactose monohydrate and microcrystalline cellulose) was investigated in order to determine the influence of formulation and manufacturing process on the lyoavailability of theophylline after compaction. After studying the role of individual excipients, the initial dissolution of a ternary blend...