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Lactose in tablets: Functionality, critical material attributes, applications, modifications and co-processed excipients

Drug Discovery Today, 2023
Lactose is one of the most widespread excipients used in the pharmaceutical industry. Because of its water solubility and acceptable flowability, lactose is generally added into tablet formulation to improve wettability and undesirable flowability. Based on Quality by Design, a better understanding of the critical material attributes (CMAs) of raw ...
Lijie Zhao, Haiyue Zhao
exaly   +3 more sources

Impact of critical process parameters and critical material attributes on the critical quality attributes of liposomal formulations prepared using continuous processing

International Journal of Pharmaceutics, 2022
Liposomes were one of the earliest drug delivery vehicles used for anti-cancer therapeutics and similarly, lipid-based nanoparticles have been used for abundance of applications as gene therapies. The methods to produce these particles have remained relatively unchanged until the recent emergence of continuous manufacturing.
Gowtham Yenduri   +2 more
exaly   +3 more sources

An update on microcrystalline cellulose in direct compression: Functionality, critical material attributes, and co-processed excipients

Carbohydrate Polymers, 2022
Microcrystalline cellulose (MCC) is one of the most popular cellulose derivatives in the pharmaceutical industry. Thanks to its outstanding tabletability, MCC is generally included in direct compression (DC) tablet formulations containing poor-tabletability active pharmaceutical ingredients.
Lan Shen, Lijie Zhao, Haiyue Zhao
exaly   +3 more sources

Low-dose capsule filling of inhalation products: Critical material attributes and process parameters

International Journal of Pharmaceutics, 2014
The aim of the present work was to identify the material attributes and process parameters of a dosator-nozzle capsule filling machine that are critical in low-fill weight capsule filling for inhalation therapies via hard-gelatin capsules. Twelve powders, mostly inhalation carriers, some fines and one proprietary active pharmaceutical ingredient (API),
Johannes Khinast, Eva Faulhammer
exaly   +3 more sources

Mannitol in direct compression: Production, functionality, critical material attributes and co-processed excipients

International Journal of Pharmaceutics
In recent years, mannitol has been widely used in the pharmaceutical industry as a substitute for lactose. Mannitol is widely available and can be produced by a variety of methods. Due to its water solubility, low hygroscopicity and chemical inertness, it is commonly added to various formulations, especially tablet formulations.
Lan Shen, Lijie Zhao, Yanlong Hong
exaly   +3 more sources

Critical factors in manufacturing multi-layer tablets—Assessing material attributes, in-process controls, manufacturing process and product performance

International Journal of Pharmaceutics, 2010
Advancement in the fields of material science, analytical methodologies, instrumentation, automation, continuous monitoring, feed forward/feed back control and comprehensive data collection have led to continual improvement of pharmaceutical tablet manufacturing technology, notably the multi-layer tablets. This review highlights the material attributes,
Sivakumar R, Vaithiyalingam   +1 more
exaly   +3 more sources

Creation of novel large dataset comprising several granulation methods and the prediction of tablet properties from critical material attributes and critical process parameters using regularized linear regression models including interaction terms

International Journal of Pharmaceutics, 2020
Our aim was to understand better the causal relationships between material attributes (MAs), process parameters (PPs), and critical quality attributes (CQAs) using an originally created large dataset and regularized linear regression models. In this study, we focused on the following three points: (1) creation of a dataset comprising several tablet ...
Yoshinori Onuki   +2 more
exaly   +3 more sources

Critical Material Attributes in Wet Granulation

2019
Arvind K. Bansal   +2 more
exaly   +2 more sources

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