Pregelatinized Starch
Pregelatinized Starch is known as a tablet and capsule diluent, tablet and capsule disintegrant, tablet binder. Pregelatinized Starch is one of the ingredients in Arvin Kala’s diverse product portfolio.
Description
Pregelatinized starch appears as a moderately coarse to fine powder, ranging in color from white to off-white. It is odorless and has a mildly characteristic taste. Under a polarizing microscope, a slurry of fully pregelatinized starch in cold water shows no significant ungelatinized granules, meaning no ‘Maltese crosses’ typical of the starch birefringence pattern. When samples are suspended in glycerin, they exhibit characteristic forms based on the drying method used during manufacturing: either irregular chunks from drum drying or thin plates. Partially pregelatinized starches (e.g., Starch 1500G and Sepistab ST200) retain birefringence patterns typical of unmodified starch granules.
Applications in Pharmaceutical Formulation or Technology
Partially pregelatinized starch is a modified starch commonly used in oral capsule and tablet formulations. It serves as a binder, diluent, and disintegrant. Compared to regular starch, partially pregelatinized starch can be produced with improved flow and compression characteristics, making it suitable as a tablet binder in dry-compression or direct compression processes. In these processes, pregelatinized starch is self-lubricating. However, when used with other excipients, a lubricant may need to be added to the formulation. Although 0.25% w/w magnesium stearate is commonly used for this purpose, higher concentrations can negatively impact tablet strength and dissolution. Therefore, stearic acid is generally preferred as a lubricant with pregelatinized starch. Partially pregelatinized starch is utilized in oral dry powder hard capsule formulations. Both partially and fully pregelatinized starch can also be used in wet granulation processes. Fully pregelatinized starches can be used in the production of soft capsules, shells, and coatings, as well as serving as binders in tablets.
Stability and Storage Conditions
Pregelatinized starch is a stable but hygroscopic material that should be stored in a well-closed container in a cool, dry place.
Method of Manufacture

Food-grade pregelatinized starches are prepared by heating an aqueous slurry containing up to 42% w/w of starch at 62 to 72°C. Chemical additives, such as gelatinization aids (salts or bases) and surfactants, may be included in the slurry to control rehydration or minimize stickiness during drying. After heating, the slurry can be spray-dried, roll-dried, extruded, or drum-dried. In the case of drum drying, the dried material can be further processed to achieve the desired particle size range.
Pharmaceutical grades of fully pregelatinized starch are prepared without additives by spreading an aqueous suspension of ungelatinized starch on hot drums, where gelatinization and subsequent drying occur. Partially pregelatinized starch is produced by applying mechanical pressure to moistened starch. The resulting material is then ground, and its moisture content is adjusted to meet specifications.

Safety
Pregelatinized starch and regular starch are widely used in oral solid-dosage formulations. Pregelatinized starch is generally considered a nontoxic and nonirritant excipient. However, consuming large amounts of pregelatinized starch orally may be harmful.
Handling Precautions
Observe standard precautions based on the circumstances and quantity of material being handled. It is recommended to use eye protection and a dust mask. To minimize the risk of explosions, avoid generating excessive dust. In the UK, the long-term (8-hour TWA) workplace exposure limits for starch are 10 mg/m³ for total inhalable dust and 4 mg/m³ for respirable dust.

Chemical-physical values

Test Item Unit Specification
Iron
ppm
NMT 20.0
Sulfur Dioxide
ml
NMT 2.7
Salmonella
g
Absent/10
E. Coli
g
Absent/1
Total Combined molds and yeasts count
CFU/g
NMT 100
Total Aerobic Microbial Count
CFU/g
NMT 1000
Test Item Unit Specification
DESCRIPTION
Moderately Coarse to fine, white to off-white powder. Odorless, slight, characteristic taste
Solubility
Slightly soluble in cold water insoluble in alcohol
PH Value
NLT 4.5 NMT 7.0
Loss on Drying
%
NMT 14.0
Residue on Ignition
%
NMT 5.0

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