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MEGGLE – Experts in Excipients: The Whole World of Lactose White Papers

MEGGLE – Experts in Excipients: The Whole World of Lactose

2nd APGI COATING WORKSHOP University of Lille, Lille, France, April 17, 2013.
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Novel Co-processed Excipient for Directly Compressed Controlled Release Formulations A novel excipient comprising 50% lactose monohydrate and 50% hypromellose K4M was prepared via co-processing, integrating the parent materials into a monoparticulate structure offering superior functional performance and simplified processing compared to simple physical admixtures of the same composition. Powder flow, tablet compaction, and wettability showed enhanced performance as a result of excipient co-processing. API dissolution studies with slight compositional modifications and simplified manufacturing method demonstrated flexibility in tablet performance without altering the API release profile.
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MODELING DRUG RELEASE FROM RETALAC® TABLETS: IMPACT OF DRUG SOLUBILITY Hydrophilic matrices are frequently used to control drug release from oral solid dosage forms. Recently, RetaLac®, a co-processed blend of 50% hydroxypropyl methylcellulose and 50% lactose monohydrate (mechanically inseparable) has been marketed. RetaLac® can be used to prepare matrix tablets by direct compression. However, yet little is known on the underlying drug release mechanisms from this type of dosage forms.
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Co-processed, lactose-based Excipients and their Performance in a First and Second Compaction Process Dry granulation processes gain growing importance in pharmaceutical industries and the number of excipients used increases steadily.
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HPMC-LACTOSE MIXTURES AS MATRIX FORMERS IN CONTROLLED RELEASE TABLETS: PHYSICAL MIXTURES VS. CO-PROCESSED BLENDS The main objective of this work was to investigate the effects of the type of preparation method of HPMC/lactose-based matrix tablets on the resulting: 􀂃flowability and compressibility of the powders/granules 􀂃drug release kinetics 􀂃dimension changes 􀂃water uptake/weight loss kinetics of the tablets upon exposure to different release media.
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Powder Flow Investigated by Different Methods, and its Relation to Functional Performance as Demonstrated by Examination of Lactose and Lactose-Based Excipients The scope of this work is to compare routinely used, often historically-based flow assessment techniques as well as newer methods, including, but not limited to, Carr's Index, Hausner Ratio, Angle of Repose, flow through an orifice, weight uniformity, and powder rheometry with regard to validity and reproducibility, focusing on a frequently used excipients and proposing the best choice of a flow method with respect to predictability of functional performance.
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Predicting Drug Release Fom HPMC/lactose Tablets Three mathematical models were applied to quantify drug release from HPMC/lactose-based matrix tablets loaded with varying amounts of theophylline: (i) a numerical model considering drug diffusion in axial and radial direction in cylinders as well as limited drug solubility effects, (ii) an analytical solution of Fick’s second law of diffusion considering axial and radial mass transport in a cylinder, but neglecting limited drug solubility effects, and (iii) a simple early time approximation of the analytical solution, considering only radial mass transport and neglecting axial diffusion as well as limited drug solubility effects.
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A Simple Mathematical Model Allowing for the Prediction of Drug Release from HPMC/Lactose-Based Controlled Release Matrix Tablets To use a simple mathematical model to quantify drug release from matrix tablets based on RetaLac®: a co-processed blend of 50% hydroxypropyl methylcellulose (HPMC) and 50% lactose monohydrate (mechanically inseparable). To use the model to quantitatively predict the impact of the formulation design on the resulting release kinetics and to evaluate the reliability of these simulations by independent experiments.
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