Hydroxypropyl methyl cellulose phthalate
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Hydroxypropyl methyl cellulose phthalate
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CAS No:
9050-31-1
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Formula:
C8H6O4.xC3H8O2.xCH4O.xUnspecified
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Chemical Name:
Hydroxypropyl methyl cellulose phthalate
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Synonyms:
Cellulose,hydrogen 1,2-benzenedicarboxylate,2-hydroxypropyl methyl ether;Cellulose phthalate hydroxypropyl methyl ether;HP 55;HP 50;2-Hydroxypropyl methyl cellulose phthalate;HP 55F;Hydroxypropyl methylcelluose phthalate;HP 50F;Hydroxypropyl methyl cellulose phthalate;HPMCP 55;HP 55UF;HPMCP;HP 50 (cellulose derivative);HP 5 (cellulose derivative);HP 5;HPMCP HP 55S;HP 55S;Cellulose methyl 2-hydroxypropyl ether hydrogen phthalate ester;Hypromellose phthalate;HPMCP-HP 55;HPMCP-HP 50;Glycidyl methacrylate-HPMCP copolymer;Hydroxyl propylmethylcellulose phthalate;HPMCP 50;9087-42-7;37324-31-5;42612-68-0;52624-22-3;168395-88-8;405108-66-9
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CAS No:
Description
White to off-white free-flowing flakes or granules Hypromellose phthalate occurs as white to slightly off-white, freeflowing flakes or as a granular powder. It is odorless or with a slightly acidic odor and has a barely detectable taste.
Characteristics
57.46000
3.46
Solid
1.3±0.1 g/cm3
>145 °C (dec.)(lit.)
456.7±48.0 °C at 760 mmHg
230.0±29.6 °C
1.681
H2O: Limited solubility at low pH, soluble at pH ≥4.2.soluble
Hypromellose phthalate is chemically and physically stable at ambient temperature for at least 3–4 years and for 2–3 months at 40°C and 75% relative humidity. It is stable on exposure to UV light for up to 3 months at 25°C and 70% relative humidity. Drums stored in a cool, dry place should be brought to room temperature before opening to prevent condensation of moisture on inside surfaces. After 10 days at 60°C and 100% relative humidity, 8–9% of carbyoxybenzoyl group were hydrolyzed. In genera
7.82X10-9 mm Hg at 25 deg C (est)
Safety Information
NONH for all modes of transport
1
24/25
FJ5954000
P261, P264, P270, P271, P280, P301+P310, P302+P352, P304+P340, P305+P351+P338, P312, P321, P330, P332+P313, P337+P313, P362, P403+P233, P405, P501
H300
Hydroxypropyl methyl cellulose phthalate Use and Manufacturing
Hypromellose phthalate is widely used in oral pharmaceutical
formulations as an enteric coating material for tablets or
granules. Hypromellose phthalate is insoluble in gastric fluid
but will swell and dissolve rapidly in the upper intestine. Generally,
concentrations of 5–10% of hypromellose phthalate are employed
with the material being dissolved in either a dichloromethane : ethanol
(50 : 50) or an ethanol : water (80 : 20) solvent mixture.
Hypromellose phthalate can normally be applied to tablets and
granules without the addition of a plasticizer or other film formers,
using established coating techniques. However, the addition of a
small amount of plasticizer or water can avoid film cracking
problems; many commonly used plasticizers, such as diacetin,
triacetin, diethyl and dibutyl phthalate, castor oil, acetyl monoglyceride,
and polyethylene glycols, are compatible with hypromellose
phthalate. Tablets coated with hypromellose phthalate
disintegrate more rapidly than tablets coated with cellulose acetate
phthalate.
Hypromellose phthalate can be applied to tablet surfaces using a
dispersion of the micronized hypromellose phthalate powder in an
aqueous dispersion of a suitable plasticizer such as triacetin, triethyl
citrate, or diethyl tartrate together with a wetting agent.
Hypromellose phthalate 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. Since hypromellose phthalate is tasteless and
insoluble in saliva, it can also be used as a coating to mask the
unpleasant taste of some tablet formulations. Hypromellose
phthalate has also been co-precipitated with a poorly soluble drug
to improve dissolution characteristics.
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Hydroxypropyl methyl cellulose phthalate
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