Building the quality into pellet manufacturing environment - feasibility study and validation of an in-line quantitative near infrared (NIR) method

in Talanta (2010), 83

The present study focuses on the implementation of an in-line quantitative near infrared (NIR) spectroscopic method for determining the active content of pharmaceutical pellets. The first aim was to non ... [more ▼]

The present study focuses on the implementation of an in-line quantitative near infrared (NIR) spectroscopic method for determining the active content of pharmaceutical pellets. The first aim was to non-invasively interface a dispersive NIR spectrometer with four realistic particle streams existing in the pellets manufacturing environment. Regardless of the particle stream characteristics investigated, NIR together with principal component analysis (PCA) was able to classify the samples according to their active content. Further, one of these particle stream interfaces was non-invasively investigated with a FT-NIR spectrometer. A predictive model based on Partial Least Squares (PLS) regression was able to determine the active content of pharmaceutical pellets. The NIR method was finally validated with an external validation set for an API concentration range from 80 to 120 % of the targeted active content. The prediction error of 0.9 % (root mean standard error of prediction, RMSEP) was low, indicating the accuracy of the NIR method. The accuracy profile on the validation results, an innovative approach based on tolerance intervals, demonstrated the actual and future performance of the in-line NIR method. Accordingly, the present approach paves the way for real-time release-based quality system. [less ▲]

Development of an in vitro endotoxin test for monoolein-water liquid crystalline gel for use as an implant

in Tropical Journal of Pharmaceutical Research [=TJPR] (2009), 8(6), 501-508

Purpose : Drugs that are administered by parenteral route must be apyrogenic. The aim of this study was to develop an in vitro endotoxin test for liquid crytalline gels for use as implants, using a ... [more ▼]

Purpose : Drugs that are administered by parenteral route must be apyrogenic. The aim of this study was to develop an in vitro endotoxin test for liquid crytalline gels for use as implants, using a monoolein-water liquid crystalline gel as a model. Methods : The gel-clot technique was used. The gel was dissolved first in isopropyl myristate, and the endotoxins were extracted with water for bacterial endotoxin test. Tests for the labelled lysate sensitivity and interfering factors were performed to validate the developed method. The limit of detection of endotoxin in the gel was also determined. Results : The labelled lysate sensitivity was confirmed. It was not influenced by the presence of extracts from the gels. Endotoxins in the contaminated test gels were completely extracted. Endotoxin concentration in the tested gels was below the calculated threshold endotoxin level. Conclusion : A method to perform in vitro endotoxins test of liquid crystalline gels was successfully developed and validated. Application of the technique to gels currently being developed in our laboratories indicate that the gels were apyrogenic. [less ▲]

Development of a new topical system: Drug-in-cyclodextrin-in-deformable liposome

in International Journal of Pharmaceutics (2009), 380(1-2), 174-180

A new delivery system for cutaneous administration combining the advantages of cyclodextrin inclusion complexes and those of deformable liposomes was developed, leading to a new concept: drug ... [more ▼]

A new delivery system for cutaneous administration combining the advantages of cyclodextrin inclusion complexes and those of deformable liposomes was developed, leading to a new concept: drug-incyclodextrin-in-deformable liposomes. Deformable liposomes made of soybean phosphatidylcholine (PC) or dimyristoylphosphatidylcholine (DMPC) and sodium deoxycholate as edge activator were compared to classical non-deformable liposomes. Liposomes were prepared by the film evaporation method. Betamethasone, chosen as the model drug,was encapsulated in the aqueous cavity of liposomes by the use of cyclodextrins. Cyclodextrins allowan increase in the aqueous solubility of betamethasone and thus, the encapsulation efficiency in liposome vesicles. Liposome size, deformability and encapsulation efficiency were calculated. The best results were obtained with deformable liposomes made of PC in comparison with DMPC. The stability of PC vesicles was evaluated by measuring the leakage of encapsulated calcein on the one hand and the leakage of encapsulated betamethasone on the other hand. In vitro diffusion studies were carried out on Franz type diffusion cells through polycarbonate membranes. In comparison with non-deformable liposomes, these new vesicles showed improved encapsulation efficiency, good stability and higher in vitro diffusion percentages of encapsulated drug. They are therefore promising for future use in ex vivo and in vivo experiments. [less ▲]

Quantitative in-line monitoring of pharmaceutical pellets active content using near infrared spectroscopy

Poster (2009, August)

Betamethasone in cyclodextrin in deformable liposomes for dermal applications: ex vivo diffusion studies

Poster (2009, June 07)

Development of an intraperitoneal implant for abdomino-pelvic chronic diseases

Poster (2009, June)

Studies for understanding the interactions between biological membranes and cyclodextrins and their effects at the cell level

Poster (2009, June)

Preparations and characterisations of semi-solid formulations containing a hydrophilic drug for vaginal administration

Poster (2009, April 01)

The purpose of this study is to demonstrate the effect of different types of semi-solid formulations (aqueous gels, liquid jellified emulsions and hydrophilic or lipophilic creams) for vaginal ... [more ▼]

The purpose of this study is to demonstrate the effect of different types of semi-solid formulations (aqueous gels, liquid jellified emulsions and hydrophilic or lipophilic creams) for vaginal administration on the release kinetic of a hydrophilic drug. This drug is an acidic and hydrophilic (log P (octanol/water) = -3.3) molecule with an aqueous solubility upper than 170mg/ml at pH 6-8. The formulations characterisations consisted in the in vitro evaluation of the drug release kinetic and the measure of all formulations viscosity as well as the creams stability and emulsions droplets size. [less ▲]

Development of a new cutaneous delivery system: drug in cyclodextrin in deformable liposomes

Poster (2009, March 09)

Développement d'un implant intra-péritonéal contre l'endométriose

Scientific conference (2009, February 03)