Hypromellose phthalate

BP Hypromellose phthalate JP Hydroxypropylmethylcellulose phthalate PhEur Hypromellosi phthalas USPNF Hypromellose phthalate 

Cellulose phthalate hydroxypropyl methyl ether HPMCP hydroxypropyl methylcellulose benzene-1,2-dicar boxy late 2-hydroxypropyl methylcellulose phthalate methylhydroxypro-pylcellulose phthalate. 

Cellulose, hydrogen 1,2-benzenedicarboxylate, 2-hydroxypro-pyl methyl ether [9050-31-1] 

Hypromellose phthalate is a cellulose in which some of the hydroxyl groups are replaced with methyl ethers, 2-hydro-xypropyl ethers, or phthalyl esters. Several different types of hypromellose phthalate are commercially available with molecular weights in the range 20 000-200 000. Typical average values are 80 000-130 000.  

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 along with a wetting agent.  

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Cellulose acetate hypromellose phthalate polyvinyl acetate phthalate. 

Hydroxyethyl cellulose hydroxyethylmethyl cellulose hydroxypropyl cellulose hypromellose phthalate methylcellulose. 

Carboxymethyl cellulose cellulose acetate cellulose acetate phthalate cellulose, microcrystalline ethylcellulose hypromellose hypromellose phthalate hydroxyethyl cellulose hydroxy-propyl cellulose methylcellulose. 

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. 

Hypromellose phthalate occurs as white to slightly off-white, free-flowing flakes or as a granular powder. It is odorless or with a slightly acidic odor and has a barely detectable taste. 

Moisture content hypromellose phthalate is hygroscopic it takes up 2-5% of moisture at ambient temperature and humidity conditions. For the moisture sorption isotherm of HP-50 measured at 25°C, see Figure 1. 

Table II Solubility of hypromellose phthalate (HP-50 and HP-55, Shin-Etsu Chemical Co. Ltd.].

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 general, hypromellose pbthalate is more stable than cellulose acetate phthalate. At ambient storage conditions, hypromellose phthalate is not susceptible to microbial attack. 

The addition of more than about 10% titanium dioxide to a coating solution of hypromellose phthalate, which is used to produce a colored film coating, may result in coating with decreased elasticity and resistance to gastric fluid. ... 

Hypromellose phthalate is prepared by the esterification of hypromellose with phthalic anhydride. The degree of alkyloxy and carboxybenzoyl substitution determines the properties of the polymer and in particular the pH at which it dissolves in aqueous media. 

Hypromellose phthalate is widely used, primarily as an enteric coating agent, in oral pharmaceutical formulations. Chronic and acute animal feeding studies on several different species have shown no evidence of teratogenicity or toxicity associated with hypromellose phthalate.Hypromellose phthalate is generally regarded as a nonirritant and nontoxic material. 

Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection and gloves are recommended. Although no threshold limit value has been set for hypromellose phthalate, it should be handled in a well-ventilated environment and the generation of dust should he minimized. 

Various grades of hypromellose phthalate are available with differing degrees of substitution and physical properties, e.g., grades HP-50, HP-55, and HP-55S (Shin-Etsu Chemical Co Ltd). See Table III. 

To dissolve hypromellose phthalate in acetone ethanol (95%) or dichloromethane alcohol solvent systems, the hypromellose phthalate should first be well dispersed in alcohol before adding acetone or dichloromethane. When using acetone dichloromethane, hypromellose phthalate should be first dispersed in the dichloromethane and then the acetone added to the system. A specification for hypromellose phthalate is contained in the Food Chemicals Codex (FCC). 

Cellulose acetate phthalate hypromellose phthalate poly-methacrylates shellac. 

Although hypromellose and HPMCAS are the dominant cellulosics utilized in the solubilization of poorly soluble drug compounds, most cellulosics accepted as an excipient for pharmaceutical formulation have been studied. These polymers, shown in Table 27.4, include MC, hypromellose phthalate (HPMC-P), EC, carboxymethyl ethylcellulose, hydroxypropyl cellulose, and sodium carboxymethylcellulose. 

Hydroxypropyl methylcellulose phthalate Synonyms HPMCP Hypromellose phthalate Definition A monophthalic acid ester of hydroxypropyl methylcellulose Properties Wh. powd., odorless, tasteless pract. insol. in water... 

Hypromellose phthalate. See Hydroxypropyl methyicelluiose phthalate HyPure A. See Hypochlorous acid HyPure C. See Chloric acid HyPure CCF-HB. See Sodium hypochlorite HyPure K. See Potassium hypochlorite HyPure L. See Lithium hypochlorite HyPure N. See Sodium hypochlorite... 

The most commonly used polymers for the MBP process are HPMCAS (L, M, and H grades) and polymethacrylate-based polymers, e.g., Eudragit LlOO, LlOO-55, and S100. Other ionic polymers such as cellulose acetate phthalate (CAP), hypromellose phthalate (HP), polyvinyl acetate phthalate (PVAP), and cationic polymer Eudragit El00 can also be used. The polymer use levels are determined based on the drug loading and amorphous form stability. 

An enteric-coated delivery system of MPA was developed with the aim that it would minimize gastrointestinal side effects [55]. Myfortic, approved by the FDA in 2004, is an enteric formulation of mycophenolate sodium (EC-MPS), which releases the active MPA moiety. The enteric coating of the tablet consists of the polymer, hypromellose phthalate combined with titanium dioxide, iron oxide yellow, and indigotine (180 mg tablet) or iron oxide red (360 mg tablet) [56]. Hypromellose phthalate is a monoph-thalic acid ester of hydroxypropyl methylcellulose which dissolves at pH 5-5.5, thereby affording delivery of MPA to the small intestine rather than the stomach. 

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