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Amprac 01 is a water-based polymer for controlled drug delivery of solid dosage forms.

Functions: Carrier, Coating System

Dosage Form: Capsules, Tablets

Labeling Claims: BSE-free, Gluten-free, Non-GMO, TSE-free

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), FDA 21 CFR Regulations, JECFA (FAO/WHO), National Formulary (NF), United States Pharmacopeia (USP)

Technical Data Sheet
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Knowde Enhanced TDS

Identification & Functionality

Pharma & Nutraceuticals Functions
Substance

Modified maize starch (E 1420)

Features & Benefits

Applications & Uses

Dosage Form
Uses
  • This versatile product can be used in a wide range of additives and excipients for improving storage stability, taste and odor masking, pH-dependent solubility, and protection of sensitive actives from gastric fluid.
  • Amprac 01 may also be used for protection of the gastric mucosa from aggressive drugs, clear or colored coating, and using in existing coating equipments.

Properties

Insoluble in
Cold water
Dispersible in
Hot water
Typical Properties
ValueUnitsTest Method / Conditions
Maximum Concentration of Dispersion25.0%

Regulatory & Compliance

Conform To
  • European Pharmacopeia Addendum 2000 (EP)
  • USP 24/NF 19 (USP)
  • FOOD CHEMICALS CODEX, III edition
  • JECFA specifications
  • FAO FOOD AND NUTRITION PAPER 52/2
  • US code of Federal Regulations 21 CFR, 1995 par. 172 . 892
  • GMO free, BSE/TSE free, Gluten free

Technical Details & Test Data

Preparation
  • Disperse in hot water uo to 70°C and stir for 45 min.
  • Plasticizer must be added (Glycerol, Sorbitol, TEC, etc.) as well as antisticking agents (Talc, Magnesium Stearate, etc.).
  • Pigments can be added (Food dyes and natural colors)
List of Excipients

Plasticizer: Glycerine, Triethyl Citrate, Polysorbate, Sorbitol

Release Modifier: Shellac, Carnauba Wax, Gum Arabic, Cellulose

Glidant: Talc, PVP and other of this class of substances