From:  Acid-hydrolyzed nanocrystalline starch excipients for direct-compression tableting: a systematic review

 Comparative synthesis of acid-hydrolyzed nanocrystalline starch preparation methods.

ComparisonEvidence from reviewed studiesInterpretation
Highest reported crystallinityHCl hydrolyzed Dioscorea starch showed relative crystallinity up to 71.3%; ethanol-acid penetration with dry heating showed crystallinity of 61.22%; supercritical CO2 pretreatment followed by enzymatic hydrolysis showed crystallinity of 60.2%.HCl hydrolysis can produce high crystallinity, but newer assisted methods may also improve crystallinity while reducing processing time.
Highest reported yieldDry-heated oxalic acid hydrolysis showed the highest reported yield of 89.6%, followed by H2SO4 hydrolysis of cassava starch with yield of 85.66%.High yield does not necessarily indicate better nanocrystalline quality because higher yield may occur with lower crystallinity. Yield and crystallinity should therefore be interpreted together.
Shortest preparation timeUltrasound assisted H2SO4 hydrolysis produced particles within 45 min, while mixed HCl/H2SO4 hydrolysis reduced preparation time to 1 h.Assisted hydrolysis methods are promising for time reduction, but their reproducibility, crystallinity retention, and suitability for pharmaceutical processing require further confirmation.
Operational simplicityConventional HCl or H2SO4 hydrolysis.These methods are widely reported and technically simple, but they often require long hydrolysis times and may produce low yield.
Potential scalabilityHeat moisture pretreatment followed by H2SO4 hydrolysis, mixed acid hydrolysis, and organic acid-based hydrolysis.These approaches may offer better balance between processing time, operational simplicity, yield, and product quality, but scale-up evidence remains limited.
Potential pharmaceutical suitabilityMethods that produce reproducible crystallinity, minimize harsh processing concerns, and generate material suitable for drying, agglomeration, or direct-compression evaluation.Pharmaceutical suitability cannot be judged by crystallinity alone; residual acid control, batch reproducibility, flowability, compactibility, and excipient safety also need consideration.
Direct-compression relevanceSpray dried or agglomerated acid hydrolyzed starch excipients reporting flow indices, compression force/pressure, tensile strength or hardness, friability, disintegration, dilution capacity, and lubricant sensitivity.Direct compression relevance is strongest when studies evaluate tablet performance, not only particle preparation.