Bromelain Powder

Single-ingredient bromelain enzyme reference formula at 500 mg per serving, developed as a capsule or tablet.

Bromelain is a reference formula for brands building a single-ingredient proteolytic enzyme product at a default amount of 500 mg of bromelain per serving. Bromelain is the only active ingredient, so the development work centers on enzyme activity rather than weight: the activity unit and level of the raw material, moisture and heat protection of a protein, and the capsule or tablet system that carries it.

Capsule is the lead format because 500 mg of enzyme powder fits one standard capsule with a flow agent, and a tablet version uses a coated compression system. Options of 150, 450 and 1,000 mg sit beside the default, and the amount and the activity target are decisions for the brand and its market review.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Bromelain500 mg (default amount)Bromelain powder from pineapple stem, specified by enzyme activity in the unit the supplier states; 500 mg bromelain powder per servingA different activity grade of bromelain, with the powder weight recalculated so that the enzyme activity per serving is kept

Amounts are stated as mg of bromelain powder. Bromelain is a crude extract that contains several closely related proteinases [2], so the weight of powder does not fix the enzyme activity. Activity is expressed in a unit that the supplier states, such as gelatin digestion units or milk clotting units, and the units are not converted into one another on this page. The activity unit, the activity per gram and the label statement are set in the specification.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around enzyme and digestive nutrition. Bromelain is included as the single active so that the activity grade, the amount and the excipient system can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Enzyme nutritionBromelainIncluded because bromelain is a crude extract from the pineapple that contains various closely related proteinases, with antiedematous, antiinflammatory, antithrombotic and fibrinolytic activities shown in vitro and in vivo [2]. Evidence: Referenced
Inflammatory markers in trialsBromelainA systematic review of 7 randomized trials found that bromelain, alone or combined, reduced inflammatory parameters in most studies, and concluded that the overall effect is inconsistent because of population heterogeneity, doses, duration and parameters, with mainly gastrointestinal and well-tolerated side effects [1]. Evidence: Mixed

The amount is one stated tier. The trials in [1] used 200 to 1,050 mg per day for bromelain alone, so amount, activity target, claims and target market are brand decisions reviewed for each sales market.

Available Formats

The bromelain 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 capsule500 mg60 or 120 capsulesCellulose, calcium stearate, silica, vegetable cellulose capsule shellLead format; enzyme powder in a standard fill
Tablet1 tablet500 mg60 or 100 tabletsMicrocrystalline cellulose, croscarmellose sodium, stearic acid, enteric or film coatCoated compressed unit that limits exposure to moisture

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the labeled powder weight at an assumed 100% assay of the powder as purchased, so 500 mg of bromelain powder per unit is used as the input; the enzyme activity follows from the grade and is fixed in the specification.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Capsule500 mg powder580 mg per capsule80 mgFlow, fill weight variation, moisture, enzyme activity assay
Tablet500 mg powder700 mg tablet weight200 mgCompression behavior, hardness, disintegration, coating integrity, enzyme activity assay

Powder, liquid and gummy versions are separate projects, because an enzyme in a dissolving or chewable system needs its own activity retention and taste work.

Formulation Considerations

Activity, not weight. Two lots of bromelain powder at 500 mg can differ widely in activity. The specification names the activity unit and the activity per gram, and the content check of finished units is an activity assay rather than a weight check.
Heat and moisture. Proteinases lose activity with heat, moisture and compression force. Blend humidity, low-heat processing, a gentle compression setting for tablets and a desiccant in the bottle are set early, and activity through shelf life is measured by assay.
Coating choice. An enteric coat can be considered for brands that want release in the intestine rather than the stomach, which changes the release specification and the dissolution test. Whether a coat is used is decided together with the intended claim and the target market.
Evidence and tier. The review in [1] calls the effect on inflammation inconsistent and asks for standardization of dose, duration and condition, and the review in [2] notes that the activities depend only partly on proteolytic activity. Amount, claims and the dose limit for each sales market are reviewed before a product is developed.

Customization Options

Brands adjust the amount per serving, the activity grade, the format and the coating.

ParameterRangeNote
Powder per serving150, 450, 500 or 1000 mgOptions for the brand; unit size follows the powder weight
Activity gradeSet with the supplier in GDU or another stated unitChanges the activity per serving and the input weight
FormatCapsule or tabletPowder, liquid and gummy are separate projects
CoatingNone, film coat or entericSets protection from moisture and the release behavior
Add-onsPapain, trypsin, curcuminAnother enzyme or botanical adds activity assays and a stability check

The pilot run confirms flow and fill weight of the enzyme powder, tablet hardness and coating integrity, and the enzyme activity 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 (500 mg on the label of CF001547; example DSLD labels 9444, 26542, 69133). The label names the ingredient as bromelain; a pineapple stem bromelain powder is set as the form.
SpecificationSet in formulationBromelain powder, 500 mg per serving, with enzyme activity in the unit and level stated by the supplier; activity assay, moisture and microbial 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] Pereira IC, Sátiro Vieira EE, de Oliveira Torres LR, et al. Bromelain supplementation and inflammatory markers: A systematic review of clinical trials. Clin Nutr ESPEN. 2023;55:116-127. DOI · PubMed<br>[2] Maurer HR. Bromelain: biochemistry, pharmacology and medical use. Cell Mol Life Sci. 2001;58(9):1234-45. DOI · PubMed

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