SAIB(sucrose isobutyrate acetate) is a pharmaceutical grade multifunctional excipient. It is a viscous liquid prepared by controlled esterification of natural sugar (sucrose) with acetic acid and isobutyric anhydride. It is a mixture produced by distillation and highly purified production. It can be used as a sustained release agent material, solvent/carrier and drug abuse inhibitor.

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SAIB product characteristics

SAIB is an excellent solvent/carrier for hydrophobic API and has slow release function.

SAIB does not crystallize and remains amorphous at room temperature, which greatly promotes a constant rate of drug delivery;

SAIB is non-polymeric and does not coagulate or precipitate when in contact with aqueous body fluids. SAIB is soluble in many organic solvents and compatible with many materials; SAIB can be dispersed in water with the help of organic solvents.

SAIB has bioadhesive properties and can be used for transdermal, sublingual and buccal patch applications.

Product application

1. Delay release

In the figure above, it can be seen that SAIB has an HLB value of about 5, indicating that it is hydrophobic

2. Poor water solubility API solution

Hydrophobic SAIB is a good solvent/carrier for API with poor water solubility, and the use of SAIB improves the solubility of commercially insoluble drugs.

3. Prevent drug abuse

The use of SAIB increases the particle size of opioids during grinding and interferes with drug extraction.

(1) Polymers (polyoxyethylene and/or hydroxypropyl methylcellulose) and tocopherol acetate are granules made from an alcohol solution of SAIB. The preparations are classified as either Uncured /Uncured or heat-cured /Cured(cured 90oC for 30 minutes).

(2) Pseudoephedrine hydrochloride, polymers (polyoxyethylene and/or hydroxypropyl methylcellulose) and tocopherol acetate are granules made from an alcohol solution of SAIB. The preparations are classified as either Uncured /Uncured or heat-cured /Cured(cured 90oC for 30 minutes).

The nasal abuse assessment showed that SAIB use increased the powder size at the time of grinding, with up to 47% of the grinding powder size greater than 1mm.

Compared with the control group, the extraction amount of SAIB in water, 0.1%N HCl and 0.1%N NaOH solvents decreased by 41.3%-42.5%, 24.8%-26.1% and 37.4%-50.6%, respectively. The use of organic solvents for extraction produces sticky residues that are difficult to pass through various routes of administration (e.g., injection, ingestion, snorting, etc.), preventing drug abuse

conclusion

The use of SAIB, without coating, can be directly mixed with API to prolong drug release and achieve sustained release.

Hydrophobic SAIB, which can be dispersed in water with the help of organic solvents, can be used with hydrophobic or hydrophilic apis; SAIB can improve the solubility of API with poor water solubility and is an excellent solvent and carrier for API with poor water solubility.

The use of SAIB prevents drug abuse by increasing the particle size of the drug when it is ground, interfering with drug extraction, and making it difficult for the drug to be absorbed through various routes of administration.

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