Therapeutic-Dose Sublingual Lozenge — 25 mg — research-stage spec (NOT for sale)

This is NOT a product. It is engineering documentation.

Psilocybin is Schedule I under the U.S. Controlled Substances Act. We do not sell, distribute, or market this product. The specification on this page exists to document what such a product would look like if/when the regulatory pathway permits. The email waitlist below is purely for opt-in notification if/when that happens — it is not a pre-order, and we will never accept payment for a Schedule I substance.

Product description

Hypothetical product specification for a 25 mg psilocybin sublingual lozenge intended for use in licensed therapeutic settings (e.g. Oregon Measure 109 service centers, hypothetical FDA-approved therapeutic protocols, or hypothetical clinical-trial supply). The 25 mg dose is the most-studied therapeutic dose in published research, including the Johns Hopkins and Imperial College trials cited below. Form factor is a sublingual lozenge rather than capsule for two reasons: (1) faster onset (15-25 min sublingual vs 45-60 min oral); (2) avoidance of first-pass hepatic metabolism, producing more consistent peak plasma concentrations across patients. Dissolution profile is targeted at 8-10 minutes complete dissolution under the tongue. This is not a consumer product spec — it's a clinical-supply spec. The intended end-user is a licensed therapist or service-center facilitator administering psilocybin within a regulatory framework that explicitly permits it. As of today, no such framework exists at federal level. We publish this spec to demonstrate readiness — if/when the regulatory environment permits clinical-grade psilocybin products, we have done the manufacturing-design work to be a serious supply partner. Waitlist email below; no purchase, no commerce, no marketing of an active controlled substance.

Manufacturing notes

API: pharmaceutical-grade synthesized psilocybin (preferred over fruit-body extraction for clinical use due to dose precision and absence of co-occurring tryptamines). Alternative formulation using cultivated extract is also specified. Lozenge base is xylitol + isomalt + natural flavorings, designed for sublingual dissolution.

QA / testing protocol

[1]HPLC-MS quantification per lot — target ±2% from label claim (tighter than supplement-grade)

[2]Dissolution profile testing — target 80% release at 8 min sublingual

[3]Microbial limits per USP <61> — pharmaceutical-grade

[4]Heavy metal panel per USP <232>

[5]Residual solvent testing per ICH Q3C

[6]Stability study — full ICH Q1A protocol

[7]Bioequivalence study (if reformulated from clinical-trial supply)

Regulatory pathway

FDA Investigational New Drug (IND) pathway for clinical trials currently active for several psilocybin indications. Compass Pathways' COMP360 received FDA Breakthrough Therapy Designation for treatment-resistant depression in 2018. Usona Institute's psilocybin received Breakthrough Designation for major depressive disorder in 2019. A finished, marketable therapeutic-context product is contingent on (1) successful Phase III trial completion and (2) FDA approval — neither has occurred as of this writing.

References

[1] Davis, A.K. et al. (2021). Effects of psilocybin-assisted therapy on major depressive disorder. JAMA Psychiatry, 78(5), 481-489.(2021)doi:10.1001/jamapsychiatry.2020.3285

[2] Carhart-Harris, R.L. et al. (2021). Trial of psilocybin versus escitalopram for depression. NEJM, 384(15), 1402-1411.(2021)doi:10.1056/NEJMoa2032994

[3] Griffiths, R.R. et al. (2016). Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer. Journal of Psychopharmacology, 30(12), 1181-1197.(2016)

Therapeutic-Dose Sublingual Lozenge — 25 mg