# Evidence: food effect

Parent: — · class: transport and absorption · names merged here: food effect

4 papers measured or used it, 5 only mentioned it (of 207 kept papers). Papers in year order; each section heading ends with the paper's category / subcategory. Generated by tools/build_evidence.py from registry/concepts.csv and the cards; do not edit.

## 2020 Hate — Influence of Drug-Silica Electrostatic Interactions on Drug Release from Mesoporous Silica-Based Oral Delivery Systems · Mesoporous silica / Mesoporous silica

[2020-hate-drug-silica-electrostatic-interactions-mesoporous-release](../../../cards/2020-hate-drug-silica-electrostatic-interactions-mesoporous-release/paper.html) · Mesoporous silica / Mesoporous silica · used · as: food effect

| id | kind | content | locator |
|---|---|---|---|
| R10 | record, measured | KET release in two-step tests (total drug release %, mean ± SD, n = 3) — P6; KET-MPS; shift at 30 min (two points plotted at 30 min, before and after the shift) — sub-table below; text: complete release in low pH media; on shift to pH 5.5 or 6.8 the dissolved amount decreased by almost 30-35%; fed-state sequence 70% release at pH 4.5 and no further release on raising the pH to 5.5; discussion: an appreciable 30% drop in solution concentration | Fig. 5a, p.16; text p.15, p.21 |
| C33 | claim, generalisation, authors: "predicting" | Two-step dissolution under fed-state pH conditions (pH 4.5 to 5.5) performed like the fasted-state sequences, predicting no food effect on KET-MPS performance from a pH perspective [rests on: R10] | p.21 |
| X14 | extractor note | claim-data gap — C33 ("predicting no food effect ... from a pH perspective") rests on KET-MPS: fed sequence ≈68.5% against ≈70% (pH 1 to 5.5) and ≈69% (pH 1 to 6.8) at 120 min (R10). For ATZ-MPS the fed sequence released ≈38.5% against ≈63-75% for the fasted sequences (R12) — C33, R10, R12 — limit the no-food-effect statement to KET-MPS |  |

## 2023 Nguyen — Enteric coating of tablets containing an amorphous solid dispersion of an enteric polymer and a weakly basic drug: A strategy to enhance in vitro release · Dissolution / B. Supersaturation from ASD dissolution

[2023-nguyen-enteric-coating-delamanid-hpmcp-asd-release](../../../cards/2023-nguyen-enteric-coating-delamanid-hpmcp-asd-release/paper.html) · Dissolution / B. Supersaturation from ASD dissolution · measured · as: food effect

| id | kind | content | locator |
|---|---|---|---|
| R13 | record, measured | DLM equilibrium solubility (µg/mL, mean ± SD where printed) — buffers and biorelevant media (P13) — sub-table below; text: FeSSIF V2 4.4-fold higher than FaSSIF V1; FEDGAS pH 4.5 and fed-state intestinal medium approximately 650- and 100-fold higher than the corresponding buffers | Fig. 6, p.7; text p.6, p.9 |
| R14 | record, measured | release of Deltyba tablets in biorelevant media (µg/mL) — uncoated Deltyba, single stage; FaSSIF V1 and FeSSIF V2 by in situ UV (P8), FEDGAS by HPLC (P9) — sub-table below; text: FeSSIF initially rapid then more gradual, up to 80 µg/mL after 120 min; maximum 35 µg/mL in FaSSIF | Fig. 7, p.7; text p.8 |
| R16 | record, measured | release profiles of coated tablets in biorelevant intestinal media (µg/mL) — enteric-coated DLM edisylate ASD tablets, single stage, FaSSIF V1 and FeSSIF V2 (P10, P16) — sub-table below; text: near-complete release after a 10-20 min lag in both media | Fig. 8A, p.8; text p.8 |
| R17 | record, measured | release in FeSSIF V2 after 17 h in FEDGAS (µg/mL) — enteric-coated DLM edisylate ASD tablets, 17 h in FEDGAS pH 3.0 or 4.5, then transfer to FeSSIF V2 (P12) — sub-table below; text: extent of release after transfer reached approximately 90 µg/mL | Fig. 8B, p.8; text p.8 |
| R24 | record, cited | food effect on Deltyba pharmacokinetics — clinical studies (EMA, 2013, ref 13) — 200 mg dose with a standard meal: Cmax 3.4-fold and AUC0-inf 2.9-fold versus fasted; single 400 mg dose: mean Cmax +327% (high-fat meal) and +213% (standard meal), AUC0-inf +347% and +206%, versus fasting; high variability between subjects | p.9 |
| C49 | claim, generalisation, authors: "likely" | Food-dependent solubility and dissolution likely contribute to the positive food effect on bioavailability of poorly soluble drugs (posaconazole, ziprasidone, pretomanid); Deltyba also shows improved fed-state exposure with high inter-subject variability [rests on: R13, R24; cited: refs 13, 30, 42, 70] | p.9 |

## 2023 Nguyen — Fed- and Fasted-State Performance of Pretomanid Amorphous Solid Dispersions Formulated with an Enteric Polymer · Bioperformance / Bioperformance

[2023-nguyen-pretomanid-hpmcas-asd-fed-fasted-performance](../../../cards/2023-nguyen-pretomanid-hpmcas-asd-fed-fasted-performance/paper.html) · Bioperformance / Bioperformance · measured · as: food effect

| id | kind | content | locator |
|---|---|---|---|
| R23 | record, measured; relative bioavailability derived (E4, E5) | mean PK parameters, mean (SD), n = 4 — single oral dose 30 mg PTM, male cynomolgus monkeys, crossover (P14-P17) — sub-table below; footnote c: p < 0.001 versus PTM-HF ASD (fasted); d: p < 0.05 versus PTM-HF-Tris ASD (fasted); e: p < 0.01 versus PTM-HF-TPGS ASD (fasted); f: p < 0.05 versus reference (fed) | Table 3, p.3181 |
| R33 | record, derived (ratio of mean Cmax and AUC0-inf in R23, relation not printed) | food effect on the reference product in monkeys — reference capsule, fed versus fasted (R23.a, R23.f) — Cmax +23%, AUC0-inf +49% (text); recomputed 1702/1385 = 1.23, 11663/7846 = 1.49 | p.3182 |
| C50 | claim, conclusion, authors: asserted ("significantly") | The crystalline reference showed a positive food effect: fed Cmax and AUC significantly higher than fasted [rests on: R23, R25] | p.3170, p.3180, p.3183 |
| C53 | claim, conclusion, authors: asserted | The HF ASD showed a negative food effect: significantly lower Cmax and lower AUC than fasted (p < 0.05); its exposure was negatively impacted by food [rests on: R23, R25] | p.3170, p.3181, p.3183 |
| C78 | claim, conclusion, authors: asserted | The higher crystalline solubility in FeSSIF translated into higher fed-state bioavailability of the crystalline reference, consistent with the clinical study; food raised Cmax and AUC0-inf by 76 and 88% in humans and by 23 and 49% in monkeys [rests on: R1.f-g, R23, R28, R33] | p.3182 |

## 2025 Junior — Release performance and crystallization of racemic and enantiopure praziquantel amorphous solid dispersion in various media · Dissolution / B. Supersaturation from ASD dissolution

[2025-alvarenga-praziquantel-racemic-enantiopure-asd-release-crystallization-media](../../../cards/2025-alvarenga-praziquantel-racemic-enantiopure-asd-release-crystallization-media/paper.html) · Dissolution / B. Supersaturation from ASD dissolution · used · as: food effect

| id | kind | content | locator |
|---|---|---|---|
| C8 | claim, generalisation, authors: could | The positive food effect of PZQ could depend on factors other than a solubility increase, which is moderate in FeSSIF-V2 [rests on: R1.i, R32] | Section 4.1, p. 1134 |
| R32 | record, cited | food effect on PZQ bioavailability (ref 49) — in vivo — high-fat and high-carbohydrate diets both increase PZQ bioavailability, the high-carbohydrate diet more | Section 4.1, p. 1134 |

## Mentioned only

- 2018 Sugihara — [2018-sugihara-pazopanib-ph-induced-supersaturation-phase-behavior](../../../cards/2018-sugihara-pazopanib-ph-induced-supersaturation-phase-behavior/paper.html) · Dissolution / C. Amorphous solubility and LLPS (ref 31)
- 2019 Elkhabaz — [2019-elkhabaz-posaconazole-asd-phase-transformations-biorelevant-media](../../../cards/2019-elkhabaz-posaconazole-asd-phase-transformations-biorelevant-media/paper.html) · Dissolution / B. Supersaturation from ASD dissolution (ref R21)
- 2020 Trasi — [2020-trasi-lumefantrine-asd-granules-solvent-evaporation](../../../cards/2020-trasi-lumefantrine-asd-granules-solvent-evaporation/paper.html) · Solid state stability / Physical stability (ref C4)
- 2022 Hiew — [2022-hiew-lumefantrine-asd-stability-dissolution-polymer-choice](../../../cards/2022-hiew-lumefantrine-asd-stability-dissolution-polymer-choice/paper.html) · Solid state stability / Miscibility and drug-polymer interactions (ref 4)
- 2023 Nguyen — [2023-nguyen-gastric-ph-variations-delamanid-enteric-polymer-asd](../../../cards/2023-nguyen-gastric-ph-variations-delamanid-enteric-polymer-asd/paper.html) · Dissolution / B. Supersaturation from ASD dissolution (ref 33)