St. John’s Wort Extract

Single-ingredient St. John’s wort extract reference formula at 300 mg per serving, developed as a capsule or tablet.

St. John’s Wort is a reference formula for brands building a single-ingredient botanical extract product at a default amount of 300 mg of St. John’s wort extract per serving. The extract is the only active ingredient, so the development work centers on the standardization of the extract (hypericin and hyperforin), the herb-drug interaction profile of the ingredient, and the label statements that go with it in each sales market.

Capsule is the lead format because a 300 mg extract fits a small standard capsule, and a tablet version uses a compression system with a coating. Options of 450 and 600 mg sit beside the default, and the amount and the market are decisions for the brand and its market review. Of all the botanicals in this batch, this ingredient has the most documented interactions with medicines, which shapes the whole specification.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
St. John’s Wort300 mg (default amount)St. John’s wort herb extract standardized to hypericins, for example the St. John’s Wort Extract 0.3% Total Hypericins grade; specification 300 mg extract per serving, hypericin and hyperforin content set with the supplierGeneral St. John’s Wort Extract Powder with a different marker content, with the input recalculated so that the hypericin amount per serving is kept

Amounts are stated as mg of St. John’s wort extract, not of hypericins or hyperforin. A 300 mg serving of a 0.3% total hypericin extract carries about 0.9 mg of total hypericins, and the grade, the hyperforin content and the extraction solvent are part of the specification.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around botanical mood nutrition. St. John’s wort extract is included as the single active so that the standardization, the amount and the excipient system can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Traditional botanical nutritionSt. John’s WortIncluded because extracts of Hypericum perforatum, popularly called St. John’s wort, are widely used in some countries for patients with depressive symptoms [1]. Evidence: Referenced
Mood studiesSt. John’s WortA Cochrane review of 29 trials with 5,489 patients found marked heterogeneity in the placebo-controlled trials, with a combined response rate ratio of 1.28 in the nine larger trials and 1.87 in the nine smaller trials [1]. Evidence: Mixed

The extract weight is the stated amount, and the grade moves the dose of the marker compounds. A review of interactions reports that St. John’s wort preparations are potent activators of the pregnane-X receptor and inducers of CYP3A4 and P-glycoprotein [2], so amount, claims, target market and label warnings are brand decisions reviewed for each sales market.

Available Formats

The St. John’s wort reference formula is built for a capsule version and a tablet version; counts per serving are design choices that the brand can adjust.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Capsule1 capsule300 mg extract60 or 120 capsulesCellulose, magnesium stearate, silica, capsule shellLead format; extract in a small fill
Tablet1 tablet450 mg extract60 or 100 tabletsMicrocrystalline cellulose, croscarmellose sodium, stearic acid, opaque film coatCoated unit that contains the color and taste

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the labeled extract weight at an assumed 100% assay of the extract as purchased, so 300 mg of extract per capsule and 450 mg per tablet are used as the inputs; the marker content follows from the grade and is fixed in the specification.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Capsule300 mg extract380 mg per capsule80 mgFlow, fill weight variation, hypericin and hyperforin assay, moisture
Tablet450 mg extract600 mg tablet weight150 mgCompression behavior, hardness, disintegration, coating integrity, marker assay

Powder, liquid and gummy versions are separate projects, because a light-sensitive extract with a strong color needs its own matrix and stability work in those systems.

Formulation Considerations

Hyperforin and the interaction profile. The review in [2] reports that the degree of CYP3A4 induction correlates significantly with the hyperforin content of the preparation. The hyperforin content of the extract is therefore a specification item next to hypericin, and the choice between a standard and a low-hyperforin grade is made with the target market in mind.
Medicine interactions. The same review lists documented pharmacokinetic interactions of St. John’s wort with cyclosporine, digoxin, tacrolimus, indinavir, warfarin, alprazolam, simvastatin and oral contraceptives [2]. Label warnings and the markets that are served are reviewed before a product is developed.
Light and color. Hypericin-containing extracts are dark and sensitive to light. An opaque shell or coat, an amber bottle and marker content through shelf life are tested in stability work.
Extract or herb powder. The reference labels pool extracts with herb powders and liquid extracts. Powders carry far less marker per milligram and have a different interaction profile, so they are kept as separate projects rather than options on this page.

Customization Options

Brands adjust the extract weight, the marker grade, the format and the label warnings.

ParameterRangeNote
Extract per serving300, 450 or 600 mgExamples for the brand; capsule count or tablet weight follows the chosen tier
Marker grade0.3% total hypericins; hyperforin set separatelyChanges the marker doses and the interaction profile
FormatCapsule or tabletPowder, liquid and gummy are separate projects
Pack size30 to 120 unitsSet by the brand
Add-onsVitamin B complex, magnesiumAnother active adds fill weight and a second assay to the release plan

The pilot run confirms flow and fill weight of the extract blend, color and coating behavior of the tablet, and the hypericin and hyperforin assay of the first units against the specification.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (300 mg on the label of CF000151; example DSLD labels 949, 6438, 26413). The label names the ingredient as St. John’s wort extract; a hypericin-standardized herb extract is set as the form.
SpecificationSet in formulationSt. John’s wort herb extract, 300 mg per serving, standardized to hypericins with hyperforin content stated; marker assays, solvent residue, pesticide and heavy-metal limits and method are fixed with the supplier. Unit size, fill weight and stability are set in formulation.
Data sourceNIH DSLDDSLD v9.4.0, downloaded 2026-01-10: 50,824 reference formulas merged from on-market labels with complete ingredient amounts. Counts show how labels are distributed.
Market reviewPer marketDose limits, labeling and claims are reviewed for each sales market before a finished product is developed.
ReferencesSources[1] Linde K, Berner MM, Kriston L. St John’s wort for major depression. Cochrane Database Syst Rev. 2008;2008(4):CD000448. DOI · PubMed<br>[2] Nicolussi S, Drewe J, Butterweck V, et al. Clinical relevance of St. John’s wort drug interactions revisited. Br J Pharmacol. 2020;177(6):1212-1226. DOI · PubMed

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