Salts, Solvates and Hydrates of Multi-kinase Inhibitor Drug Pazopanib with Hydroxybenzoic Acids

CrystEngComm ◽  
2021 ◽  
Author(s):  
Sunil Rai ◽  
Debjani Baidya ◽  
Ashwini Nangia
Keyword(s):  
Dissolution Rate ◽  
Classification System ◽  
Kinase Inhibitor ◽  
Biopharmaceutics Classification System ◽  
Hydroxybenzoic Acids ◽  
Inhibitor Drug ◽  
Biopharmaceutics Classification

The marketed formulation of Pazopanib (PAZ) suffers from low and variable bioavailability because of its poor dissolution rate and photostability issues. The drug falls under Biopharmaceutics Classification System (BCS) Class...

scholarly journals Review: Effect of Different Methods on the Multicomponents Crystal Formation from Medicinal Natural Ingredient Compounds

2021 ◽  
Vol 6 (5) ◽  
pp. 32-39
Author(s):  
Eldya Nurismi ◽  
Henni Rosaini ◽  
dan Maria Dona Octavia
Keyword(s):  
Dissolution Rate ◽  
Classification System ◽  
Solvent Evaporation ◽  
Biopharmaceutics Classification System ◽  
Crystal Formation ◽  
High Permeability ◽  
Dissolution Rates ◽  
Solubility In Water ◽  
Low Solubility ◽  
Biopharmaceutics Classification

Solubility is an important parameter for the bioavailability of drugs that are difficult to dissolve. Natural compounds that are included in class II in the Biopharmaceutics Classification System (BCS) are Apigenin, Quercetin, Genistein, Curcumin, and Piperin. These drugs have low solubility in water and high permeability so that they affect the dissolution rate and as well as their bioavailability, to increase the solubility they are made with multicomponent crystals. This review aims to provide information on the method of making crystal multicomponent to increase the solubility and dissolution rate of BCS II drugs. Several methods that can be used in multicomponent are solvent drop grinding, solvent evaporation, assisted grinding, and slurry. The results showed that multicomponent crystals using several methods could increase the solubility and dissolution rates.

scholarly journals ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 363
Author(s):  
Claudia Miranda ◽  
Alexis Aceituno ◽  
Mirna Fernández ◽  
Gustavo Mendes ◽  
Yanina Rodríguez ◽  
...  
Keyword(s):  
Latin American ◽  
Classification System ◽  
Biopharmaceutics Classification System ◽  
In Vitro Dissolution ◽  
Ich Guidelines ◽  
Latin American Region ◽  
Regulatory Guidelines ◽  
Biopharmaceutics Classification

The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized guideline for biowaivers based on the biopharmaceutics classification system and the BCS regulatory guidelines in Latin America and analyzes the current BCS regulatory requirements and the perspective of the harmonization in the region to develop safe and effective multisource products. Differences and similarities between the official and publicly available BCS guidelines of several Latin American regulatory authorities and the new ICH harmonization guideline were identified and compared. Only Chile, Brazil, Colombia, and Argentina have a more comprehensive BCS guideline, which includes solubility, permeability, and dissolution requirements. Although their regulatory documents have many similarities with the ICH guidelines, there are still major differences in their interpretation and application. This situation is an obstacle to the successful development of safe and effective multisource products in the Latin American region, not only to improve their access to patients at a reasonable cost, but also to develop BCS biowaiver studies that fulfill the quality standards of regulators in developed and emerging markets.

scholarly journals COMPARISON OF GLOBAL REGULATORY GUIDELINES FOR AVAILABILITY OF DIFFERENT BIOWAIVER PROVISIONS AND APPLICATION REQUIREMENTS OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER.

2018 ◽  
Vol 3 (3) ◽  
pp. 8-20
Author(s):  
Jimi Patel ◽  
Priti Mehta ◽  
Vaishali Kothari
Keyword(s):  
Development Strategy ◽  
Classification System ◽  
Drug Application ◽  
Biopharmaceutics Classification System ◽  
New Drug ◽  
Novel Approach ◽  
Permeability Study ◽  
New Drug Application ◽  
Biopharmaceutics Classification

To waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows greater number of Biowaiver submissions and the wider use of In-vitro permeability study. Biowaiver is a beneficial approach for getting approval of Abbreviated New Drug Application (ANDA) while, BCS based Biowaiver is the novel approach to gain approval for New Drug Application (NDA) as well as ANDA. A Biopharmaceutics Classification System (BCS) based Biowaiver is an exemption from conducting human bioequivalence studies when active ingredient and dosage form meet criteria of solubility, permeability and dissolution. The Paper covers different kind of Biowaiver approaches and the criteria for the applicability of BCS based Biowaivers in the different geographic scopes with regard to global development strategy. There is a comparison of global guidelines on provisions availability for different types of Biowaiver approaches as well as for requirements of Biowaiver based on BCS. From comparison of different global guidelines it is reviewed that most of the guidance resembles to the USFDA, EU and WHO guidelines because most of the regulatory authorities are following the BCS based Biowaiver concept as one of the three main guidance documents (USFDA, EMA, WHO) or a combination of specific requirements.

The utility of rat jejunal permeability for biopharmaceutics classification system

2009 ◽  
Vol 35 (12) ◽  
pp. 1496-1502 ◽  
Author(s):  
Parvin Zakeri-Milani ◽  
Hadi Valizadeh ◽  
Hosnieh Tajerzadeh ◽  
Ziba Islambulchilar
Keyword(s):  
Classification System ◽  
Biopharmaceutics Classification System ◽  
Biopharmaceutics Classification
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