Advances in coamorphous drug delivery systems.
10.1016/j.apsb.2018.08.002
- Author:
Qin SHI
1
;
Sakib M MOINUDDIN
1
;
Ting CAI
1
Author Information
1. State Key Laboratory of Natural Medicines, Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China.
- Publication Type:Journal Article
- Keywords:
API, active pharmaceutical ingredient;
AUC, area under plasma concentrations-time curve;
BCS, bio-pharmaceutics classification systems;
Bioavailability;
Characterization;
Cmax, maximum plasma concentration;
Coamorphous;
Css, plasma concentration at steady state;
DSC, differential scanning calorimetry;
DVS, dynamic vapor sorption;
Dc, relative degree of crystallization;
Dissolution;
FT-IR, fourier transform infrared spectroscopy;
HME, hot melt extrusion;
HPLC, high performance liquid chromatography;
IDR, intrinsic dissolution rate;
LFRS, low-frequency Raman spectroscopy;
LLPS, liquid—liquid phase separation;
MTDSC, modulated temperature differential scanning calorimetry;
NMR, nuclear magnetic resonance;
P-gp, P-glycoprotein;
PXRD, powder X-ray diffraction;
Physical stability;
Preparation;
RH, relative humidity;
SEM, scanning electron microscope;
TGA, thermogravimetric analysis;
Tg, glass transition temperature;
Tmax, time of maximum plasma concentration;
UV, ultraviolet spectroscopy
- From:
Acta Pharmaceutica Sinica B
2019;9(1):19-35
- CountryChina
- Language:English
-
Abstract:
In recent years, the coamorphous drug delivery system has been established as a promising formulation approach for delivering poorly water-soluble drugs. The coamorphous solid is a single-phase system containing an active pharmaceutical ingredient (API) and other low molecular weight molecules that might be pharmacologically relevant APIs or excipients. These formulations exhibit considerable advantages over neat crystalline or amorphous material, including improved physical stability, dissolution profiles, and potentially enhanced therapeutic efficacy. This review provides a comprehensive overview of coamorphous drug delivery systems from the perspectives of preparation, physicochemical characteristics, physical stability, and performance. Furthermore, the challenges and strategies in developing robust coamorphous drug products of high quality and performance are briefly discussed.