56
J. Knapik-Kowalczuk et al.
BDS
Broadband Dielectric Spectroscopy
DSC
Differential Scanning Calorimetry
EZB
Ezetimibe
FLU
Flutamide
G-T
Gordon-Taylor
HN
Havriliak-Negami
HME
Hot Melt Extrusion
KVA
Kollidon VA64
®
LDL
Low-density lipoprotein
NPC1L1 Niemann-Pick C1-Like1
NIM
Nimesulid
NSAID Non-steroidal anti-inflammatory drug
NMR
Nuclear Magnetic Resonance
PCS
Photon Correlation Spectroscopy
PVAc
Poly vinylacetate
PVP
Poly vinylpyrrolidone
PALS
Positron Annihilation Lifetime Spectroscopy
PBC
Probucol
QENS
Quasielastic Neutron Scattering
R&D
Research and Development
SOP
Soluplus
®
TMDSC Temperature-Modulated Differential Scanning Calorimetry
THz
Terahertz spectroscopy
TSDC
Thermally Stimulated Depolarization Current
TTS
Time–Temperature Superposition
VFT
Vogel−Fulcher−Tammann equation
XRD
X-ray diffraction
1 Introduction
The Biopharmaceutics Classification System (BCS) categorizes Active Pharmaceutical Ingredients (APIs) based on their aqueous solubility and intestinal permeability
into four groups [1]. Drugs belonging to BCS class I are characterized by high
permeability and high solubility. Pharmaceuticals from II BCS class have also high
permeability, but unfortunately, they reveal low solubility. The opposite situation,
i.e. high solubility but low permeability, can be found in APIs from BCS class III,
while the last—IV—BCS group consists of drugs revealing low solubility together
with low permeability. The solubility in the BCS is defined in relation to the highest
dose strength in an immediate-release product. An API is considered highly soluble
when the highest dose strength is soluble in 250 mL or less of aqueous media over
the pH range of 1–7.5 at 310 K. The permeability classification in the BCS is based
directly on the extent of intestinal absorption of an API in humans or indirectly on the
J. Knapik-Kowalczuk et al.
BDS
Broadband Dielectric Spectroscopy
DSC
Differential Scanning Calorimetry
EZB
Ezetimibe
FLU
Flutamide
G-T
Gordon-Taylor
HN
Havriliak-Negami
HME
Hot Melt Extrusion
KVA
Kollidon VA64
®
LDL
Low-density lipoprotein
NPC1L1 Niemann-Pick C1-Like1
NIM
Nimesulid
NSAID Non-steroidal anti-inflammatory drug
NMR
Nuclear Magnetic Resonance
PCS
Photon Correlation Spectroscopy
PVAc
Poly vinylacetate
PVP
Poly vinylpyrrolidone
PALS
Positron Annihilation Lifetime Spectroscopy
PBC
Probucol
QENS
Quasielastic Neutron Scattering
R&D
Research and Development
SOP
Soluplus
®
TMDSC Temperature-Modulated Differential Scanning Calorimetry
THz
Terahertz spectroscopy
TSDC
Thermally Stimulated Depolarization Current
TTS
Time–Temperature Superposition
VFT
Vogel−Fulcher−Tammann equation
XRD
X-ray diffraction
1 Introduction
The Biopharmaceutics Classification System (BCS) categorizes Active Pharmaceutical Ingredients (APIs) based on their aqueous solubility and intestinal permeability
into four groups [1]. Drugs belonging to BCS class I are characterized by high
permeability and high solubility. Pharmaceuticals from II BCS class have also high
permeability, but unfortunately, they reveal low solubility. The opposite situation,
i.e. high solubility but low permeability, can be found in APIs from BCS class III,
while the last—IV—BCS group consists of drugs revealing low solubility together
with low permeability. The solubility in the BCS is defined in relation to the highest
dose strength in an immediate-release product. An API is considered highly soluble
when the highest dose strength is soluble in 250 mL or less of aqueous media over
the pH range of 1–7.5 at 310 K. The permeability classification in the BCS is based
directly on the extent of intestinal absorption of an API in humans or indirectly on the