Results 1 to 10 of about 10,215,756 (277)

Impact of Critical Material Attributes (CMAs)-Particle Shape on Miniature Pharmaceutical Unit Operations. [PDF]

AAPS PharmSciTech, 2021
AbstractThe U.S. Food and Drug Administration (FDA) emphasizes drug product development by Quality by Design (QbD). Critical material attributes (CMAs) are a QbD element that has an impact on pharmaceutical operations and product quality. Pharmaceutical drugs often crystallize as needle-shaped (a CMA) particles and affect the process due to poor ...
Azad MA, Capellades G, Wang AB, Klee DM, Hammersmith G, Rapp K, Brancazio D, Myerson AS.   +7 more
europepmc   +8 more sources

Influence of raw material properties upon critical quality attributes of continuously produced granules and tablets

European Journal of Pharmaceutics and Biopharmaceutics, 2014
Continuous manufacturing gains more and more interest within the pharmaceutical industry. The International Conference of Harmonisation (ICH) states in its Q8 'Pharmaceutical Development' guideline that the manufacturer of pharmaceuticals should have an enhanced knowledge of the product performance over a range of raw material attributes, manufacturing
Chris Vervaet, Elisabeth Peeters, Björn-Hendrik Peters   +2 more
exaly   +5 more sources

On Identification of Critical Material Attributes for Compression Behaviour of Pharmaceutical Diluent Powders. [PDF]

Materials (Basel), 2017
As one of the commonly-used solid dosage forms, pharmaceutical tablets have been widely used to deliver active drugs into the human body, satisfying patient’s therapeutic requirements. To manufacture tablets of good quality, diluent powders are generally used in formulation development to increase the bulk of formulations and to bind other inactive ...
Zhang J, Wu CY, Pan X, Wu C.
europepmc   +5 more sources

Impact of Critical Material Attributes of HPMC on the Release of Gliclazide from Hydrophilic Matrix Tablets

British Journal of Pharmacy, 2022
The influence of HPMC viscosity and the degree of substitution hydroxypropyl level (DSHP) on the release rate of gliclazide was examined. The increase in the HPMC viscosity led to a significant decrease in the release rate.
Carsten Huettermann , Heiko Feldmann
doaj   +2 more sources

Critical material attributes (CMAs) of strip films loaded with poorly water-soluble drug nanoparticles: III. Impact of drug nanoparticle loading. [PDF]

Int J Pharm, 2017
Polymer strip films have emerged as a robust platform for poorly water-soluble drug delivery. However, the common conception is that films cannot exceed low drug loadings, mainly due to poor drug stability, slow release, and film brittleness. This study explores the ability to achieve high loadings of poorly water-soluble drug nanoparticles in strip ...
Krull SM, Moreno J, Li M, Bilgili E, Davé RN.   +4 more
europepmc   +4 more sources

Critical material attributes (CMAs) of strip films loaded with poorly water-soluble drug nanoparticles: I. Impact of plasticizer on film properties and dissolution. [PDF]

Eur J Pharm Sci, 2016
Recent studies have demonstrated polymer films to be a promising platform for delivery of poorly water-soluble drug particles. However, the impact of critical material attributes, for example plasticizer, on the properties of and drug release from such films has yet to be investigated.
Krull SM, Patel HV, Li M, Bilgili E, Davé RN.   +4 more
europepmc   +4 more sources

Defining the critical material attributes of lactose monohydrate in carrier based dry powder inhaler formulations using artificial neural networks. [PDF]

AAPS PharmSciTech, 2014
The study aimed to establish a function-based relationship between the physical and bulk properties of pre-blended mixtures of fine and coarse lactose grades with the in vitro performance of an adhesive active pharmaceutical ingredient (API). Different grades of micronised and milled lactose (Lactohale (LH) LH300, LH230, LH210 and Sorbolac 400) were ...
Kinnunen H, Hebbink G, Peters H, Shur J, Price R.   +4 more
europepmc   +5 more sources

Bioactive PLA Filament with Antibacterial and Ion-Releasing Properties for Additive Manufacturing of Bone Scaffolds: QbD-Guided Development [PDF]

Pharmaceutics
Background/Objectives: The development of multifunctional biomaterials for bone regeneration remains a key challenge in additive manufacturing. Although polylactic acid (PLA) is widely used in fused deposition modeling (FDM), its limited bioactivity and ...
Anastassiya Khrustaleva, Azamat Yedrissov, Dmitriy Khrustalev, Ivan Chernykh, Aleksandr Samorodov, Saule Akhmetova, Artyom Savelyev, Marlen Kiikbayev, Polina Rusyaeva, Vladimir Kazantsev, Kristina Perepelitsyna, Sofiya Shapovalenko   +11 more
doaj   +2 more sources

Proactive-residence time distribution method for determining low-risk setpoints of critical material attributes in pharmaceutical continuous manufacturing

International Journal of Pharmaceutics
In recent years, the pharmaceutical manufacturing industry has been working towards adopting continuous manufacturing of drug product to improve productivity. However, the complexity of integrated processes makes quality assurance difficult. In pharmaceutical manufacturing, the required product quality is achieved by maintaining the critical material ...
Manabu Kano, Keita Yaginuma, Shuichi Tanabe   +2 more
exaly   +5 more sources

Usage of compaction simulators for the powder compression characterization: Advantages and limitations [PDF]

Arhiv za farmaciju, 2022
Compaction simulators are designed as machines which can provide an in-depth analysis of the powder compaction process. Characterization of the powder compression and compaction process, as well as material characterization, play an important role in the
Nikolić Nenad, Miletić Tijana, Kovačević Jovana, Medarević Đorđe, Ibrić Svetlana   +4 more
doaj   +1 more source