Evaluation of In-Line Raman Spectroscopic Monitoring of Size Reduction during Wet Media Milling of Biopharmaceutics Classification System Class II Drugs

2014 ◽  
Vol 68 (12) ◽  
pp. 1411-1417 ◽  
Author(s):  
Ye Ying ◽  
Afolawemi Afolabi ◽  
Ecevit Bilgili ◽  
Zafar Iqbal
Keyword(s):  
Classification System ◽  
Class Ii ◽  
Biopharmaceutics Classification System ◽  
Size Reduction ◽  
Raman Spectroscopic ◽  
Spectroscopic Monitoring ◽  
Biopharmaceutics Classification System Class ◽  
Media Milling ◽  
Biopharmaceutics Classification

Novel Solid Forms of Insomnia Drug Suvorexant with Improved Solubility and Dissolution: Accessing Salts from Salt-Solvates Route

CrystEngComm ◽  
2021 ◽  
Author(s):  
Suman Gundlapalli ◽  
Ramesh Devarapalli ◽  
Ramesh Reddy Mudda ◽  
Ramanaiah Chennuru ◽  
Ravi Chandra Babu Rupakula
Keyword(s):  
Receptor Antagonist ◽  
Classification System ◽  
Class Ii ◽  
Biopharmaceutics Classification System ◽  
High Permeability ◽  
Poor Solubility ◽  
Bcs Class Ii ◽  
Biopharmaceutics Classification

Suvorexant (SRX) is a dual orexin receptor antagonist used for the treatment of insomnia. It belongs to the Biopharmaceutics Classification System (BCS) class-II with high permeability and poor solubility in...

scholarly journals Lipid Based Formulations of Biopharmaceutics Classification System (BCS) Class II Drugs: Strategy, Formulations, Methods and Saturation

2016 ◽  
Vol 60 (4) ◽  
pp. 63-69
Author(s):  
I. Šoltýsová ◽  
D. Toropilová ◽  
T. de Vringer
Keyword(s):  
Classification System ◽  
Physical Stability ◽  
Chemical Properties ◽  
Class Ii ◽  
Biopharmaceutics Classification System ◽  
Biorelevant Media ◽  
Physico Chemical ◽  
Limited Series ◽  
Biopharmaceutics Classification

Abstract Active ingredients in pharmaceuticals differ by their physico-chemical properties and their bioavailability therefore varies. The most frequently used and most convenient way of administration of medicines is oral, however many drugs are little soluble in water. Thus they are not sufficiently effective and suitable for such administration. For this reason a system of lipid based formulations (LBF) was developed. Series of formulations were prepared and tested in water and biorelevant media. On the basis of selection criteria, there were selected formulations with the best emulsification potential, good dispersion in the environment and physical stability. Samples of structurally different drugs included in the Class II of the Biopharmaceutics classification system (BCS) were obtained, namely Griseofulvin, Glibenclamide, Carbamazepine, Haloperidol, Itraconazol, Triclosan, Praziquantel and Rifaximin, for testing of maximal saturation in formulations prepared from commercially available excipients. Methods were developed for preparation of formulations, observation of emulsification and its description, determination of maximum solubility of drug samples in the respective formulation and subsequent analysis. Saturation of formulations with drugs showed that formulations 80 % XA and 20 % Xh, 35 % XF and 65 % Xh were best able to dissolve the drugs which supports the hypothesis that it is desirable to identify limited series of formulations which could be generally applied for this purpose.

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.

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