DHEA

DHEA reference formula at an example 25 mg per serving, developed as a capsule or tablet.

DHEA is a reference formula for brands building a single-ingredient dehydroepiandrosterone product around example amounts of 5 to 100 mg per serving, with 25 mg shown as the example. DHEA is the only active ingredient, so the development work centers on a potent steroid raw material in a small fill: micronized particle size, blend uniformity, cleaning control between products and the market status of the ingredient.

Capsule is the lead format because a micronized DHEA powder at 25 mg blends into a standard fill, while the tablet carries the same active in a direct-compression system. Amounts are examples for the brand, and each sales market is reviewed before any amount is chosen.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
DHEA25 mg (example amount)Dehydroepiandrosterone, micronized powder; specification 25 mg DHEA per servingNon-micronized grade with the same milligram amount and a longer blending step

Amounts are stated as mg of dehydroepiandrosterone (C19H28O2, 288.4 g/mol; PubChem CID 5881). DHEA is the free steroid, so no salt conversion applies. Reference labels name the ingredient as dehydroepiandrosterone or DHEA, and some state a micronized grade.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around healthy-aging nutrition. DHEA is included as the single active so that the grade, the amount and the excipient system can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Healthy-aging nutritionDHEAA review describes DHEA as the most abundant steroid hormone in primates, with synthesis that grows and then declines over life, and notes that high circulating DHEA is suggested as a marker of longevity [1]. Evidence: Referenced
Neurosteroid researchDHEAThe same review describes potential neuroprotective, pro-cognitive, anxiolytic and antidepressant effects of DHEA and its sulfate, with clinical evidence mainly in hypoadrenal individuals and in depression with cognitive disorders [1]. Evidence: Mixed

The amounts are examples that a brand moves up or down for its market. The review in [1] also notes that DHEA is classified as a dietary supplement in some countries and that misuse in healthy people is increasing, so amount, claims and market are brand decisions reviewed per market.

Available Formats

The DHEA 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 capsule25 mg60 or 90 capsulesVegetable cellulose, flow agent, magnesium stearate, capsule shellLead format; micronized powder in a small fill
Tablet1 tablet25 mg60 or 100 tabletsCellulose, binder, disintegrant, lubricantCompressed unit

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the labeled amount divided by the assumed assay of the raw material, taken at 100% DHEA, so 25 mg of DHEA needs 25 mg of micronized powder per unit.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Capsule25 mg200 mg per capsule175 mgBlend uniformity, fill weight variation, content assay
Tablet25 mg220 mg tablet weight195 mgContent uniformity, hardness, disintegration, content assay

Liquid and powder-drink versions are separate projects, because DHEA is a lipophilic steroid and a liquid would need its own solubilizer and stability work.

Formulation Considerations

Potent active in a small fill. At 25 mg in a 200 mg capsule the active is about 12% of the fill. A micronized grade, a defined blending order and content uniformity testing across the first units decide whether the blend holds, and a premix is added if the amount tier moves to 5 mg.
Cleaning and segregation. A steroid raw material calls for cleaning validation and for rules on shared equipment before it is handled in a multi-product facility. This is set with the manufacturing site at the start of the project.
Particle size and release. A micronized grade shortens dissolution time but is cohesive and flows poorly, so glidant level and blend moisture are checked before fill weights are fixed.
Market status. The review in [1] notes that DHEA is a dietary supplement in some countries only, so the sales markets are screened first, and any market where DHEA is controlled is excluded before development starts.

Customization Options

Brands adjust the amount per serving, the grade, the format and the labeling for each market.

ParameterRangeNote
Amount per serving5, 10, 25, 50 or 100 mgExample amounts for the brand; each tier is checked against the rules of the sales market
GradeMicronized or standard powderAffects flow, blending time and dissolution
FormatCapsule or tabletLiquid and powder-drink are separate projects
Pack size30 to 120 unitsSet by the brand
Add-onsCalcium, vitamin DA second active reshapes the fill weight and the uniformity plan

The pilot run confirms flow and blend uniformity of the micronized powder, capsule fill weight, tablet hardness, and the content assay of the first units against the labeled 25 mg.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (25 mg on the label of CF025711; example DSLD labels 257464, 264020, 264541). The label names the ingredient as DHEA; micronized dehydroepiandrosterone is set as the form.
SpecificationSet in formulationDehydroepiandrosterone, micronized, 25 mg per serving; assay, particle size and impurity 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] Nenezic N, Kostic S, Strac DS, et al. Dehydroepiandrosterone (DHEA): Pharmacological Effects and Potential Therapeutic Application. Mini Rev Med Chem. 2023;23(8):941-952. DOI · PubMed

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