General Description
Synonyms: Amido; amidon; amilo; amylum; C*PharmGel; Eurylon; fecule; Hylon; maydis amylum; Melojel; Meritena; oryzae amylum; Pearl; Perfectamyl; pisi amylum; Pure-Dent; Purity 21; Purity 826; solani amylum; tritici amylum; Uni-Pure.
Description: Starch occurs as an odorless and tasteless, fine, white to off-white powder. It consists of very small spherical or ovoid granules or grains whose size and shape are characteristic for each botanical variety
Chemical Name: Starch
Functions
Tablet and capsule diluent; tablet and capsule disintegrant; tablet binder; thickening agent.
Uses
Starch is a versatile excipient used primarily in oral solid-dosage formulations where it is utilized as a binder, diluent, and disintegrant.
As a diluent, starch is used for the preparation of standardized triturates of colorants, potent drugs, and herbal extracts, facilitating subsequent mixing or blending processes in manufacturing operations.
Starch is also used in dry-filled capsule formulations for volume adjustment of the fill matrix and to improve powder flow, especially when using dried starches. Starch quantities of 3–10% w/w can act as an antiadherent and lubricant in tableting and capsule filling.
Starch, particularly the fine powders of rice and wheat starch, is also used in topical preparations for its absorbency of liquids.
Starch paste is used in ointment formulations, usually in the presence of higher ratios of glycerin.
Starch has been investigated as an excipient in novel drug delivery systems for nasal, and other site-specific delivery systems.
The retrogradation of starch can be used to modify the surface properties of drug particles.
Starches are useful carriers for amorphous drug preparations, such as pellets with immediate or delayed drug release obtained, for example, by melt extrusion, and they can improve the bioavailability of poorly soluble drugs.
Starch, particularly rice starch, has also been used in the treatment of children’s diarrheal diseases.
Specific starch varieties with a high amylose content (resistant starches) are used as insoluble fiber in clinical nutrition, and also for colon-targeting applications.
Due to their very high gelatinization temperature, these starches are used in extrusion/spheronization processes.
Starches with a high amylopectin content (waxy starches) are used as the starting material for the synthesis of hydroxyethyl starch, a plasma volume expander.
Native starches conforming to pharmacopeial specifications are used as the raw materials for the production of starch-based excipients and active pharmaceutical ingredients, frequently covered with their own pharmacopeial monographs.
Incompatibilities
Starch is incompatible with strongly oxidizing substances. Colored inclusion compounds are formed with iodine.
Safety
Starch is an edible food substance, considered a food ingredient and not a food additive. It is regarded as an essentially nontoxic and nonirritant material.(25) Starch is therefore widely used as an excipient in pharmaceutical formulations.
Handling Precautions
Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection and a dust mask are recommended. Excessive dust generation should be avoided to minimize the risks of explosion. The minimal explosive concentration of corn starch is 30–60 g/m3 air
Related Substances
Dextrin; hydroxypropyl starch; maltodextrin; sodium starch glycolate; starch, pregelatinized; starch, sterilizable maize.