Results 31 to 40 of about 741 (144)

Articulation of Quality By Design Elements for Product Development and its Unique Applications [PDF]

, 2020
Quality by Design (QbD) is a methodical approach to pharmaceutical product development that begins with predefined objectives and emphasizes product and process comprehension and process control based on sound science and quality risk management ...
Sitre, Dnyaneshwar, Kamble, Ravindra
core   +1 more source

Establishing a Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) for Continuous Hot-Melt Extrusion of Oral Solid Dosage Forms

Iconic Research and Engineering Journals
exaly   +2 more sources

Quality by Design (QbD) Approach for a Nanoparticulate Imiquimod Formulation as an Investigational Medicinal Product

Pharmaceutics, 2023
The present article exemplifies the application of the concept of quality by design (QbD) for the systematic development of a nanoparticulate imiquimod (IMQ) emulsion gel formulation as an investigational medicinal product (IMP) for evaluation in an ...
Jonas Pielenhofer, Sophie Luise Meiser, Karsten Gogoll, Anna-Maria Ciciliani, Mark Denny, Michael Klak, Berenice M. Lang, Petra Staubach, Stephan Grabbe, Hansjörg Schild, Markus P. Radsak, Hilde Spahn-Langguth, Peter Langguth   +12 more
doaj   +1 more source

Quality-by-design based fabrication of febuxostat-loaded nanoemulsion: Statistical optimization, characterizations, permeability, and bioavailability studies

Heliyon, 2023
The present work deals with QbD-based development of FEB-loaded nanoemulsion (FEB-NE) in order to enhance bioavailability and permeability. In the beginning, the risk assessment was performed on different experimental variables using the Ishikawa diagram
Vishal C. Gurumukhi, Vivek P. Sonawane, Ganesh G. Tapadiya, Sanjaykumar B. Bari, Sanjay J. Surana, Shailesh S. Chalikwar   +5 more
doaj   +1 more source

Characterization of High-Spin and Low-Spin Iron(III) Quinoxalinotetraphenylporphyrin

, 2016
The 1H NMR spectra of iron(III) quinoxalinotetraphenylporphyrin ((QTPP)FeIIIXn), iron(III) (methylquinoxalino)tetraphenylporphyrin ((MQTPP)FeIIIXn), and iron(III) pyrazinotetraphenylporphyrin ((PTPP)FeIIIXn) have been studied to elucidate the impact of ...
Jacek Wojaczyński (2961273), Lechosław Latos-Grażyński (2464375), Tadeusz Głowiak (2974758)   +2 more
core   +2 more sources

A Cost Effective (QbD) Approach in the Development and Optimization of Rosiglitazone Maleate Mucoadhesive Extended Release Tablets – In Vitro and Ex Vivo [PDF]

Advanced Pharmaceutical Bulletin, 2019
Purpose: The purpose of the study was to develop and optimize rosiglitazone maleate mucoadhesive extended-release tablets by quality by design (QbD) approach.
Suryaprakash Reddy Chappidi, Eranti Bhargav, Venkataranganna Marikunte, Haranath Chinthaginjala, Mallela Vijaya Jyothi, Muralidhar Pisay, Mounika Jutur, Mujahid Shaik Mahammad, Mrunalini Poura, Sailaja Yadav, Moinuddin Syed   +10 more
doaj   +1 more source

Evaluations of Quality by Design (QbD) Elements Impact for Developing Niosomes as a Promising Topical Drug Delivery Platform

Pharmaceutics, 2020
Topical corticosteroids are used to treat a variety of skin conditions such as allergic reactions, eczema, and psoriasis. Niosomes are a novel surfactant-based delivery system that may be used to deliver desoximetasone via topical product application in ...
Parinbhai Shah, Benjamin Goodyear, Anika Haq, Vinam Puri, Bozena Michniak-Kohn   +4 more
doaj   +1 more source

Development of Bedaquiline-Loaded SNEDDS Using Quality by Design (QbD) Approach to Improve Biopharmaceutical Attributes for the Management of Multidrug-Resistant Tuberculosis (MDR-TB)

Antibiotics, 2023
Background: The ever-growing emergence of antibiotic resistance associated with tuberculosis (TB) has become a global challenge. In 2012, the USFDA gave expedited approval to bedaquiline (BDQ) as a new treatment for drug-resistant TB in adults when no ...
Rao Nargis Jahan, Zafar Khan, Md. Sayeed Akhtar, Mohd Danish Ansari, Pavitra Solanki, Farhan J. Ahmad, Mohd Aqil, Yasmin Sultana   +7 more
doaj   +1 more source

Optimisation of Ondansetron Orally Disintegrating Tablets Using Artificial Neural Networks [PDF]

, 2014
Purpose: To investigate the impact of critical quality attributes (CQAs) and critical process parameters (CPPs) on quality target product profile (QTPP) attributes of orally disintegrating tablet (ODT) containing ondansetron (OND) using two artificial ...
Purisa, Sevim, Purisa, S, Ozsoy, Y, Ozsoy, Yildiz, Aksu, B, AKSU, Buket, Yegen, Gizem, Cevher, E, Cevher, Erdal, Yegen, G   +9 more
core   +1 more source

Lean Six Sigma untuk Mengurangi Waste Pada Produksi Tablet Coating A [PDF]

, 2021
PT. Medica Indonesia salah satu perusahaan farmasi etikal terbesar di Indonesia. Departement Pilot Plant berperan sebagai fasilitas peningkatan skala setelah skala lab untuk memastikan bahwa QTPP (Quality Target Product Profile) secara konsisten dicapai ...
Suparno, Adizty, Kholil, M.T., Muhammad, Oktaandhini, Dhita Savira   +2 more
core   +1 more source