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Shin-Etsu AQOAT® AS-HF

CAS Number
71138-97-1
EC Number
615-255-9
Chemical Name
Hypromellose Acetate Succinate

Shin-Etsu AQOAT® AS-HF-Hypromellose acetate succinate (HPMCAS, NF, JP) is an enteric coating material that can be used in aqueous or organic media. It is also used as solubility enhancement of poorly soluble APIs.

Properties

Physical Form
  • Granules
  • Powder
  • Solid
Pharma and Nutraceuticals Functions
  • Carrier
  • Coating System
  • Controlled Release Agent
  • Extended Release Agent
  • Solubilizer

Product families

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions
  • Oral
Healthcare & Pharma — Pharmaceutical Manufacturing
  • Excipients & Coatings

Product Families

Pharmaceuticals & Nutraceuticals — Excipients
  • Carriers & Bulking Agents
  • Modified & Controlled Release
  • Pharmaceutical Coatings
  • Solvents & Solubilizers

Other characteristics

Brand
Shin-Etsu AQOAT
Functions

Carrier, Coating System, Controlled Release Agent, Extended Release Agent, Solubilizer

Dosage Form
  • Capsules, Pellets, Tablets
  • Capsules
  • Pellets
  • Tablets
Labeling Claims

Allergen-free, BSE-free, Kosher, Non-GMO, Solvent-free, TSE-free; Allergen-free; BSE-free; Kosher; Non-GMO; Solvent-free; TSE-free

Certifications & Compliance

DMF Type IV, GMP, Japan Pharmacopeia (JP), National Formulary (NF), The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA)

Note

*Viscosity of 2 w/w% solution of sodium hydroxide aqueous solution at 20oC **D 50: NMT10 μm, D 90: NMT20 μm by laser diffraction method ***D 50: 70 - 300 μm by laser diffraction method Abbreviation; HPMCAS

Grade
Pharma Grade
Markets
Healthcare & Pharma
Features

For enteric coating, various coating methods can be applied such as aqueous, organic solvent, ammonia neutralized and dry coating. Coating methods can be selected depending on the characteristic of API. For example, dry coating is suitable for water and solvent sensitive API.. Shin-Etsu AQOAT® is also used in solid dispersion for solubility and bioavailability enhancement. In order to prepare solid dispersion, various methods are applicable such as spray dry, spray coating, hot melt extrusion (HME), coprecipitation etc. As Shin-Etsu AQOAT® can dissolve into various organic solvents and has relatively low glass transition temperature (Tg), it is one of the most suitable polymers in solid dispersion. Numerous scientific papers reported that Shin-Etsu AQOAT® was able to enhance the drug solubility more effectively compared to other polymers.

Technology
Pharmaceuticals & Nutraceuticals
Packaging Type
  • Bags
  • Drums
Chemical Inventories
  • ENCS (Japan)
  • IECSC (China)
  • KECI (Korea)
  • TCSI (Taiwan)
Certifications and Compliance

DMF Type IV; GMP; Japan Pharmacopeia (JP); National Formulary (NF); The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA)

Technical data

Table 1 of 1

6 rows
CharacteristicValueUnit
Acetyl Content10.0 - 14.0%
Hydroxypropoxy Content6.0 - 10.0%
Methoxy Content22.0 - 26.0%
pH Solubilitymin. 6.5—
Succinoyl Content4.0 - 8.0%
Viscosity2.4 - 3.6mPas

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