Safety Profile
Known Safety Concerns
- NOT suitable for vegans, vegetarians, or halal/kosher consumers
- Bovine source: BSE transmission risk essentially eliminated by manufacturing but concerns persist
- Porcine source: not halal or kosher -- labelling critical
- Cross-contamination with peanut proteins reported in rare manufacturing incidents
Contraindications
- NOT suitable for vegans, vegetarians, or halal/kosher consumers
- Bovine source: BSE transmission risk essentially eliminated by manufacturing but concerns persist
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Gelatin capsules are made from bovine or porcine collagen hydrolysate. They are the most common capsule format globally. While safe, they are NOT suitable for vegans, vegetarians, or individuals with religious dietary restrictions (halal/kosher). Bovine gelatin may be of concern related to BSE prion risk in some regulatory contexts, though the manufacturing process effectively eliminates this risk. Should be distinguished from HPMC (vegetable) capsules.
Biological and Chemical Classification
- Scientific Name
- Gelatin (partially hydrolyzed collagen)
Mechanism of Action
Information not yet available for this ingredient profile.
Clinical Evidence of Effectiveness
Information not yet available for this ingredient profile.
Pharmacokinetics
Information not yet available for this ingredient profile.
Recommended Dosage
Information not yet available for this ingredient profile.
SETI — Scientific Evidence Transparency Index
Executive Summary — Ingredient Assessment
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Excipient
- Evidence consistency: High consistency across studies (100%)
- NOT suitable for vegans, vegetarians, or halal/kosher consumers
- Bovine source: BSE transmission risk essentially eliminated by manufacturing but concerns persist
- Porcine source: not halal or kosher -- labelling critical
- Cross-contamination with peanut proteins reported in rare manufacturing incidents
The available scientific evidence for Gelatin Capsule indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.
Total SETI Score
High risk| Evidence quality | 10/40 |
| Evidence consistency | 20/20 |
| Safety signals | 0/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 10 studies reported limited or advisory safety evidence (YELLOW)
Evidence Policy
Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.
Last updated: 24 მარ 2026, 09:21
Evidence Distribution
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Observational / other LOW evidence YELLOWDevelopment and Validation of an Assay Method for Levothyroxine Soft Gelatin Capsules Utilizing the RP-HPLC Technique. ↗Katari N et al.. Development and Validation of an Assay Method for Levothyroxine Soft Gelatin Capsules Utilizing the RP-HPLC Technique.. Biomed Chromatogr. 2026. PMID:41467709.PMID 41467709 ↗Journal Biomed ChromatogrYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41467709/
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Observational / other LOW evidence YELLOWTalazoparib Formulation Bridging in Cancer Patients-Challenges and the Critical Role of Model-Informed Drug Development in Approval Despite Failed Bioequivalence. ↗Wang D et al.. Talazoparib Formulation Bridging in Cancer Patients-Challenges and the Critical Role of Model-Informed Drug Development in Approval Despite Failed Bioequivalence.. CPT Pharmacometrics Syst Pharmacol. 2026. PMID:41379622.PMID 41379622 ↗Journal CPT Pharmacometrics Syst PharmacolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41379622/
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Observational / other LOW evidence YELLOWEffect of oral sesame oil gelatin capsules on episiotomy pain in primiparous women: a triple-blind randomized controlled trial. ↗Mehrabi Bardar M et al.. Effect of oral sesame oil gelatin capsules on episiotomy pain in primiparous women: a triple-blind randomized controlled trial.. Matern Health Neonatol Perinatol. 2025. PMID:41354976.PMID 41354976 ↗Journal Matern Health Neonatol PerinatolYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41354976/
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Observational / other LOW evidence YELLOWMelt-Extruded Microparticles Based On Chitosan-pectin Complex for Delayed Dissolution of Benznidazole. ↗Magi MS et al.. Melt-Extruded Microparticles Based On Chitosan-pectin Complex for Delayed Dissolution of Benznidazole.. AAPS PharmSciTech. 2025. PMID:41345376.PMID 41345376 ↗Journal AAPS PharmSciTechYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41345376/
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Observational / other LOW evidence YELLOWFunctional and Metabolomic Analyses of Chamomile Jelly Derived from Gelatin Capsule Waste with Inulin and Polydextrose as Prebiotic Sugar Substitutes. ↗Sanprasert S et al.. Functional and Metabolomic Analyses of Chamomile Jelly Derived from Gelatin Capsule Waste with Inulin and Polydextrose as Prebiotic Sugar Substitutes.. Antioxidants (Basel). 2025. PMID:41300536.PMID 41300536 ↗Journal Antioxidants (Basel)Year 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41300536/
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Observational / other LOW evidence YELLOWStabilization of Self-Pressurized Gelatin Capsules for Oral Delivery of Biologics. ↗Wood-Yang AJ et al.. Stabilization of Self-Pressurized Gelatin Capsules for Oral Delivery of Biologics.. Pharmaceutics. 2025. PMID:41012492.PMID 41012492 ↗Journal PharmaceuticsYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41012492/
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Observational / other LOW evidence YELLOWSimplex lattice design for the development of arrowroot starch and sodium alginate with calcium chloride crosslinker as a capsule shell alternative. ↗Harimurti S et al.. Simplex lattice design for the development of arrowroot starch and sodium alginate with calcium chloride crosslinker as a capsule shell alternative.. J Adv Pharm Technol Res. 2025. PMID:40901442.PMID 40901442 ↗Journal J Adv Pharm Technol ResYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40901442/
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Observational / other LOW evidence YELLOWA machine learning model (Sol_ME) assisted development of a unit-dose lipid formulation for apalutamide: formulation, pharmacokinetics, and pharmacodynamics evaluation. ↗Patel S et al.. A machine learning model (Sol_ME) assisted development of a unit-dose lipid formulation for apalutamide: formulation, pharmacokinetics, and pharmacodynamics evaluation.. Int J Pharm. 2025. PMID:40858184.PMID 40858184 ↗Journal Int J PharmYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40858184/
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Observational / other LOW evidence YELLOWDoE-Optimized Minitabs: Fabricating a Promising Modified-Release Sprinkle Formulation. ↗Borsadiya SR et al.. DoE-Optimized Minitabs: Fabricating a Promising Modified-Release Sprinkle Formulation.. Recent Adv Drug Deliv Formul. 2025. PMID:40685721.PMID 40685721 ↗Journal Recent Adv Drug Deliv FormulYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40685721/
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Observational / other LOW evidence YELLOWHigh-velocity delivery of biologics via the gastrointestinal tract by self-pressurized oral capsules. ↗Palacios JI et al.. High-velocity delivery of biologics via the gastrointestinal tract by self-pressurized oral capsules.. J Control Release. 2025. PMID:40553757.PMID 40553757 ↗Journal J Control ReleaseYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40553757/
Score Transparency
0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.
Method: Q = number of approved references ÷ 10 (capped at 1.0)
Limited — mostly case reports or animal studies
Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.
Mixed or neutral — roughly equal benefit and risk signals
Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.
One or more monitoring-level safety signals active
Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.
Final GIRI Score for Gelatin Capsule. Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
Full methodology & data sources
The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.
- References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
- Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
- Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
- Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
Risk Level Classification
Based on available regulatory signals and scientific evidence, this ingredient presents a low safety concern under normal conditions of use.
0–3.0
3.0–5.5
5.5–7.5
7.5–10
The score pin shows exactly where this ingredient falls on the fixed risk scale.
What drove the Low classification for Gelatin Capsule
A score of 1.5 places this ingredient in the Low band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
0 approved references.
Limited — mostly case reports or animal studies (Level 4–5).
Neutral or mixed — benefit and risk signals roughly balanced.
No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.
No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).
How are the Low / Moderate / High / Critical thresholds defined?
The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:
| Level | Score | Meaning |
|---|---|---|
| LOW | 0.0 – 2.9 | Sparse or predominantly beneficial evidence. No active safety alerts. |
| MODERATE | 3.0 – 5.4 | Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups. |
| HIGH | 5.5 – 7.4 | Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended. |
| CRITICAL | 7.5 – 10 | Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision. |
Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.