Application of Novel Partially Pregelatinized Cassava [tapioca] Starch as Substitute Filler-Diluent to Lactose in Personalized Substance-Abuse Therapy for Lactose Intolerant Population

This poster was presented at the AAPS 2025 by GRIFFIN GAMMA LLC

PURPOSE

A study protocol was developed to evaluate partially pregelatinized cassava [tapioca] starch as a possible substitute to lactose as a filler-diluent in personalized substance-abuse therapy for lactose intolerant population.

METHOD(S)

Prototype formulations containing naltrexone HCl (1%w/w), a blocker of the mu-opioid receptor (Naltrexone HCl, USP, Medisca, Montreal, Canada), were compounded using Lactose Monohydrate (99%w/w) as filler-diluent (Lactose, NF [Monohydrate], Medisca, Canada) and partially pregelatinized cassava [tapioca] starch (99%w/w) as filler-diluent (Cassava Starch 2060GG, Cassava Pharma, NY), respectively. Each formulation was filled into capsules with target weight of 270 mg (Capsule Coni-Snap #3, Medisca, Canada), using capsule filler (Profiller 1100, Medisca, Canada). The capsules were analyzed using USP < 2091 > (Weight Variation) and USP < 701 > (Disintegration). Further analysis was conducted based onStudent T-test(Minitab Statistical Software 22, Minitab, IL).

RESULT(S)

It was found that the Naltrexone HCl-based formulations using lactose monohydrate as filler-diluent (Batch A) and partially pregelatinized cassava [tapioca] starch as filler-diluent (Batch B), conformed toUSP < 2091 > Weight Variation, with none of the capsules exhibiting any variation outside 7.5% acceptance criteria (Table 1).

Table 1: Comparing Weight Variation in Prototype Capsule

The results also showed that all six (6) capsules in each formulation as subjected to theUSP ( < 701 > Disintegrationanalysis, met the acceptance criteria with disintegration times less than 5 minutes (Figure 1).

Figure 1: Comparing Capsule Disintegration from Prototype Formulations (USP <701>), (N=6)

Results from the Process Capability (CpK) analysis showed that both formulations demonstrated acceptable CpK values > 1.00 (Batch A was 1.05; Batch B was 1.16) [Figure 2a], an indication of stability in the encapsulation process and methodology.

Figure 2a: Process Capability Analysis based on Capsule Loading Efficiency

Furthermore, statistical estimation of difference conducted usingTwo-Sample Student T-testshowed no significant difference between the two groups (p-value: 0.005), with pooled standard deviation (8.31) and acceptable difference at 95% CI (2,27, 6.92). There was, however, slight wider variance in the data spread within the Lactose based sample group (Batch A) when compared to Tapioca-based sample group (Batch B), as shown by the individual value plot (Figure 2b). Future work will attempt to fully characterize suchwithin-groupvariance observed.

Figure 2b: Analysis of Weight Variation based on Individual Value Plots

CONCLUSION(S)

The study shows that partially pregelatinized cassava [tapioca] starch possesses qualities and attributes as a potential substitute filler-diluent to lactose in personalized substance-abuse therapy for lactose intolerant population.

Discover more in the full scientific poster on Starch as Substitute Filler-Diluent for Lactose Intolerant here

(click the picture to download the poster)

Authors: Siddiqa Patel; Mehmed Ugur ; Ahmet Bosnak ; Patrick C. Okoye
Contact: patrick[at]griffin-gamma.com

Source: GRIFFIN GAMMA AAPS poster Starch as Substitute Filler-Diluent for Lactose Intolerant