HYDROXYPROPYL METHYL CELLULOSE ACETATE SUCCINATE
- CAS NO.:71138-97-1
- Empirical Formula: C10H22O9
- Molecular Weight: 0
- MDL number: MFCD00802310
- Update Date: 2024-11-01 18:09:03
What is HYDROXYPROPYL METHYL CELLULOSE ACETATE SUCCINATE?
Chemical properties
soluble in organic solvents, including acetone, methanol, aqueous ethanol
Chemical properties
Hypromellose acetate succinate is a white to off-white powder or granules. It has a faint acetic acid-like odor and a barely detectable taste. Hypromellose acetate succinate is available in several grades, according to the pH at which the polymer dissolves (low, L; medium, M; and high, H) and its predominant particle size (cohesive fine powder, F; or free-flowing granules, G).
The Uses of HYDROXYPROPYL METHYL CELLULOSE ACETATE SUCCINATE
Hypromellose Acetate Succinate HPMCAS;is a pharmaceutical compound comprising enzalutamide.
Production Methods
Hypromellose acetate succinate is produced by the esterification of hypromellose with acetic anhydride and succinic anhydride, in a reaction medium of a carboxylic acid, such as acetic acid, and using an alkali carboxylate, such as sodium acetate, as catalyst. The fibrous reaction product is precipitated out by adding a large volume of water to the reaction medium. Purification is achieved by thorough washing with water. The granular grade of hypromellose acetate succinate that is so obtained can be pulverized to a fine powder if required.
Pharmaceutical Applications
Hypromellose acetate succinate is commonly used in oral pharmaceutical
formulations as a film coating, as well as an enteric coating
material for tablets or granules. It is a solubility enhancing agent
via solid dispersion. Hypromellose acetate succinate is insoluble in
gastric fluid but will swell and dissolve rapidly in the upper
intestine. For aqueous film-coating purposes, a dispersion of
hypromellose acetate succinate fine powder and triethyl citrate (as
a plasticizer) in water is commonly utilized. Organic solvents
can also be used as vehicles for applying this polymer as a film
coating.
Hypromellose acetate succinate may be used alone or in
combination with other soluble or insoluble binders in the
preparation of granules with sustained drug-release properties; the
release rate is pH-dependent.
Dispersions of poorly soluble drugs with hypromellose acetate
succinate are prepared using techniques such as mechanical
grinding, solvent evaporation, and melt extrusion.
Safety
The safety and pharmacological profiles of hypromellose acetate succinate are similar to those of other ether and ester derivatives of cellulose. All nonclinical studies reported in the literature identify no target organs for toxicity by hypromellose acetate succinate. It has also been reported that hypromellose acetate succinate does not alter fertility in rats, does not produce any developmental anomalies in rats and rabbits, and does not alter perinatal and postnatal development in rats when assessed up to 2500 mg/kg body-weight
storage
Hypromellose acetate succinate should be stored in a well-closed container, in a cool, dry place. In such storage conditions, hypromellose acetate succinate is a stable material. Hypromellose acetate succinate is hygroscopic. It is hydrolyzed to acetic acid and succinic acid, and the hypromellose polymer starts to form if dissolved in 1 mol/L sodium hydroxide for more than two hours. The hydrolysis is the main degradation pathway that is responsible for increasing amounts of free acids in storage, especially upon exposure to moisture.
Incompatibilities
Hypromellose acetate succinate is incompatible with strong acids or bases, oxidizing agents, and sustained levels of elevated humidity.
Regulatory Status
Included in the FDA Inactive Ingredients Database for use in oral preparations (capsules, and delayed-action preparations). Hypromellose acetate succinate has been approved for use in commercial pharmaceutical products in the USA and in Japan.
Properties of HYDROXYPROPYL METHYL CELLULOSE ACETATE SUCCINATE
Melting point: | >203°C (dec.) |
storage temp. | Hygroscopic, -20°C Freezer, Under inert atmosphere |
solubility | Practically insoluble in ethanol (95%), hexane, unbuffered
water, and xylene. On the addition of acetone, or a mixture
of ethanol (95%) and dichloromethane (1 : 1), a clear or turbid
viscous solution is produced. Hypromellose acetate succinate
also forms a clear or turbid solution in buffers of pH greater than
4.5 with the rank order of solubility for the various grades increasing with the ratio of acetyl over succinoyl
substitution. The exact pH value at which the polymer starts to
swell and dissolve depends on the buffer type and ionic strength,
although the rank order for the different grades is independent of
the buffer used. No solvent has been found to completely
dissolve hypromellose acetate succinate polymer; the resulting
clear or turbid solutions significantly scatter light in both static
and dynamic light scattering experiments, indicating that the
polymer may exist as colloids or aggregates. The data is collated
from the Shin-Etsu Chemical Co. Ltd and the research work of
the authors (R Chen, BC Hancock, and RM Shanker). |
form | Solid |
color | White to Off-White |
Stability: | Hygroscopic |
Safety information for HYDROXYPROPYL METHYL CELLULOSE ACETATE SUCCINATE
Computed Descriptors for HYDROXYPROPYL METHYL CELLULOSE ACETATE SUCCINATE
HYDROXYPROPYL METHYL CELLULOSE ACETATE SUCCINATE manufacturer
Deepak Cellulose Pvt Ltd
Arihant Innochem Pvt Ltd
New Products
(S)-3-Aminobutanenitrile hydrochloride 4-Methylphenylacetic acid N-Boc-D-alaninol N-BOC-D/L-ALANINOL Tert-butyl bis(2-chloroethyl)carbamate 3-Morpholino-1-(4-nitrophenyl)-5,6-dihydropyridin- 2(1H)-one Furan-2,5-Dicarboxylic Acid Tropic acid 1-Bromo-3,5-Di-Tert-Butylbenzene S-2-CHLORO PROPIONIC ACID ETHYL ISOCYANOACETATE 2-Bromo-1,3-Bis(Dimethylamino)Trimethinium Hexafluorophosphate 4-IODO BENZOIC ACID 3-NITRO-2-METHYL ANILINE 1-(2,4-DICHLOROPHENYL) ETHANAMINE (2-Hydroxyphenyl)acetonitrile 4-Bromopyrazole 2-(Cyanocyclohexyl)acetic acid 4-methoxy-3,5-dinitropyridine 1-(4-(aminomethyl)benzyl)urea hydrochloride 2-aminopropyl benzoate hydrochloride diethyl 2-(2-((tertbutoxycarbonyl)amino) ethyl)malonate tert-butyl 4- (ureidomethyl)benzylcarbamate Ethyl-2-chloro((4-methoxyphenyl)hydrazono)acetateRelated products of tetrahydrofuran
You may like
-
71138-97-1 Hypromellose acetate succinate 99%View Details
71138-97-1 -
71138-97-1 Hypromellose acetate succinate 99%View Details
71138-97-1 -
1975-50-4 98%View Details
1975-50-4 -
2-HYDROXY BENZYL ALCOHOL 98%View Details
90-01-7 -
2-Chloro-1,3-Bis(Dimethylamino)Trimethinium Hexafluorophosphate 221615-75-4 98%View Details
221615-75-4 -
61397-56-6 CIS BROMO BENZOATE 98%View Details
61397-56-6 -
14714-50-2 (2-Hydroxyphenyl)acetonitrile 98+View Details
14714-50-2 -
118753-70-1 98+View Details
118753-70-1