Name: Corn Starch and Pregelatinized Starch
CAS No: See Section 8
None adopted.
StarCap 1500.
See Section 8
See Section 8.
See Section 8
Corn starch and pregelatinized starch can be used in both capsules and tablets to improve flowability, enhance disintegration and improve hardness.
Corn starch and pregelatinized starch occurs as a white free-flowing powder. It is a coprocessed mixture of predominantly corn starch together with pregelatinized starch
Both corn starch and pregelatinized starch are listed as separate monographs in the JP, PhEur, and USP–NF, but the combination is not listed. See Starch, and Starch, Pregelatinized.
Acidity/alkalinity 4.5–7.0 for StarCap 1500 Iron 40.001% for StarCap 1500 Loss on drying 7–13% for StarCap 1500 Microbial content Total aerobes count 4100 cfu/g; molds and yeasts 4100 cfu/g (Escherichia coli, Pseudomonas aeruginosa, and Salmonella species absent) for StarCap 1500. Particle size distribution 9–42% retained on #120 mesh (125 m), 25–50% retained on #200 mesh (74 mm), 20–55% passing #200 mesh (74 mm) for StarCap 1500 Solubility Insoluble in water for StarCap 1500 Sulfur dioxide 40.005% for StarCap 1500
Store in sealed containers at below 308C, avoiding high humidity.
See Starch, and Starch, Pregelatinized.
Corn starch and pregelatinized starch is produced by a proprietary spray-drying technique
See Starch, and Starch, Pregelatinized
Observe normal precautions appropriate to the circumstances and quantity of material handled
Corn starch and pregelatinized starch is a coprocessed mixture of two materials both of which are regarded as nontoxic: Starch GRAS listed. Included in the FDA Inactive Ingredients Database (buccal tablets, oral capsules, powders, suspensions and tablets; topical preparations; and vaginal tablets). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients. Pregelatinized starch Included in the FDA Inactive Ingredients Database (oral capsules, suspensions, and tablets; vaginal preparations). Included in non-parenteral medicines licensed in the UK
Starch; starch, pregelatinized
Corn starch and pregelatinized starch are two of the materials that have been selected for harmonization by the Pharmacopeial Discussion Group. For further information see the General Information Chapter <1196> in the USP32–NF27, the General Chapter 5.8 in PhEur 6.0, along with the ‘State of Work’ document on the PhEur EDQM website, and also the General Information Chapter 8 in the JP XV. StarCap 1500 is a free-flowing, low-dust excipient with disintegration and dissolution properties independent of medium pH, which help promote deaggregation of the powder mass into primary drug particles and speeds up the dissolution rate of the drug substance, providing rapid disintegration across the pH range present in the human digestive tract.(1–3) The coprocessed product has been designed specifically for use in capsules and directly compressed tablets, and has enhanced physical properties that cannot be achieved by single blend. It has been reported as having excellent properties for high-dose, high-solubility capsule formulations, with low weight and good content uniformity.(1) The product acts as a compression aid, diluent, and disintegrant, which allows for robust but simple capsule and directly compressible tablet formulations