Pregelatinized starch is a pharmaceutical aid or excipient commonly used in pharmaceutical formulations as a diluent/filler, disintegrating agent or binder. Pregelatinized starch is manufactured from the starch by doing some chemical and mechanical process so it also called as pregelatinized modified starch, pregelatinized food starch, modified starch, instant starch, soluble starch and pregel/prejel starch.
What is Pregelatinized starch?
Pregelatinized starch is prepared from commercial source like corn, tapioca, potato, wheat or maize, it easily dissolves in water at room temperature without any heating step in manufacturing and becoming viscous like gelatin. It is widely used in pharmaceuticals, nutraceutical, dry mixes (soups, sauces, etc.), baby food/formula, fruit juice, dough, baked goods, hot cereals, potato products, salad dressings, gravies and also in several other industries including mining/drilling, construction, textiles.
Pregelatinized starch is used as a thickening agent, stabilizing agent, retaining moisture, binding, filling or tablet disintegrating.
Pregelatinized starch vs starch
Starch is a substance found a lot in nature, and it’s second largest after cellulose. But starch has some limitations, so we often need to modified its physical properties. One way we can change starch is by pre-gelatinization, which makes it dissolve better in cold water and swelling power of starch. This is a safe and eco-friendly method.
Pregelatinized starch have the ability to form a cold water paste. They develop viscosity without the need for heat. Pre-gelatinized starch keeps most of its original properties of starch and viscosity even after the process.
How to make Pregelatinized starch (Starch gelatinization)
There are a few common technical used to prepare pre-gelatinized starch. These include using spray drying, extrusion, or drum drying.
Following are the important steps for making of pregelatinized starch.
- Add water to the starch granule and give heat
- Swelling of the starch granule
- By breaking down of intermolecular structure of starch, its become viscous, transparent and thick paste
- Amylose leaching: As a starch is made up of Amylose and Amylopectin, after heading of starch with water Amylose leached out and amylopectin get collapsed and form a matrix which help in gel formation.
What does Pregelatinized starch excipient do in tablet formulation?
Functionalities
- Binder
- Diluent or filler
- Disintegrating agent
Applications
- Pharmaceutical grade pregelatinized starch is widely used as a binding and disintegrating agent for tablets, pills and granules, also used as filler for capsules.
- Best as dry binder, increase tablet hardness, Decrease tablet friability.
- Its self-lubricating property eliminates any negative effect on dissolution.
- Superior flow properties ideal for direct compression tableting.
- Solid dosage formulations
- Diluent/binder in direct compression and wet and dry granulation
- Diluent in capsule and powder formulations
- Slow release tablet formulations
- Baby Food
- Bakery
- Calorie / Sugar Reduction
- Confectionery
- Dairy Desserts
- Dairy Drinks
- Frozen Foods
- Functional Drinks
- Powdered Foods
- Sauces
What is another name for Pregelatinized starch?
Synonyms and Trade Names: Pregelatinised Starch, modified starch, Compressible Starch; C*PharmGel®; Insta-starch®; Lycatab® C; Lycatab® PCS; Merigel®; National® 78-1551; Pharma-Gel®; Prejel®; Sepistab® ST200; Starch® 1500 G; Unipure® WG220.
Pregelatinized starch catagory:
- Pregelatinized starch form native starch
- Pregelatinized starch form Modified starch
- Partially gelatinized starch
Is Pregelatinized starch a disintegrant?
Yes, Partially pregelatinized starches have a properties of both native and fully gelatinized starches and can be used as a binder and a disintegrant in wet granulated formulations.
Pregelatinized Starch monograph
Pregelatinised Starch is an approved pharmaceutical excipient and also included in the FDA Inactive Ingredients Database (oral capsules, suspensions, and tablets; vaginal preparations).
It is listed in the following pharmacopeia
- USP-NF
- Ph.Eur
- B.P.
- J.P.
- I.P.
Pregelatinized starch price
Price: 125.00 – 135.00 INR (Approx.)
Pregelatinized starch Manufacturers & Suppliers
- Colorcon Inc.
- Starch 1500 Partially (Partially Pregelatinised Starch)
- StarCap 1500 partially (Spray-dried Partially Pregelatinised Starch)
- Ingredion (ex National Starch)
- UNI-PURE® DW-L Starch (Partially Pregelatinised Starch)
- Roquette Freres
- LYCATAB® PGS (Fully Pregelatinised Starch)
- LYCATAB® CT (Partially Pregelatinised Starch)
- Cargill Inc.
- C*PharmGel™ (Partially Pregelatinised Starch)
- Tate & Lyle
- MIRA-GEL® Starch
- Visco Starch
- Galam
- Grain Processing Corporation
- S A Pharmachem Pvt Ltd
- Banpong Tapioca Flour Industrial Co Ltd
- Crest Cellulose
- DFE Pharma
- Karandikars Cashell Private Limited etc
Also read