Pharmaceutical-Grade Bromelain for Supplement and Nutraceutical Production
High-purity bromelain for nutraceutical, wound care, and anti-inflammatory supplement manufacturing — standardised by GDU/g with full pharmaceutical documentation.
Bromelain is one of the most widely studied plant-derived proteolytic enzymes in pharmaceutical and nutraceutical applications, with a substantial body of clinical evidence supporting its use in anti-inflammatory therapy, wound debridement, post-operative oedema reduction, sinusitis treatment, and as a digestive enzyme supplement. It is listed in pharmacopoeias, used in registered pharmaceutical products in Germany (Phlogenzym, Wobenzym N in combination with trypsin and rutin), and extensively documented in the European Scientific Cooperative on Phytotherapy (ESCOP) and Natural Medicines Comprehensive Database. For nutraceutical and supplement manufacturers, sourcing pharmaceutical-grade or high-purity bromelain requires a level of documentation, standardisation, and quality assurance that goes beyond standard industrial enzyme supply. Key specification requirements include standardised activity in GDU/g or MCU/g (milk clotting units), controlled purity metrics (protein content, specific activity ratio), microbial safety (total aerobic plate count, absence of specified pathogens), heavy metal absence, residual solvent limits, and full traceability documentation. Bromelain for supplement and pharmaceutical use is also evaluated for stability in capsule and tablet matrices, compatibility with excipients (particularly oxidative compounds that could denature the cysteine active site), and enteric coating compatibility for products designed for small intestinal delivery. Our pharmaceutical-grade bromelain is produced from Ananas comosus stem by aqueous extraction and multi-step purification, including precipitation, ultrafiltration, and spray drying. It is standardised to 1,000,000 CDU/g (casein digestion units) or 2,400 GDU/g based on validated activity assay, with specific activity ratio confirming purity. Full pharmaceutical documentation is available for US, EU, and Asian regulatory submissions. ISO 9001, HALAL, KOSHER, and Food Grade certifications are standard. Free samples with full COA are available for formulation development.
Anti-Inflammatory Supplement Formulation
Bromelain at 500–2,000 mg/day (in divided doses, standardised to 2,400 GDU/g) is used in anti-inflammatory supplement products for joint health, sports recovery, and post-surgical support. For capsule and tablet formulation, bromelain powder at 2,400 GDU/g requires 50–200 mg per dose capsule for typical clinical doses. Enteric coating is recommended for products targeting systemic anti-inflammatory effect to ensure intestinal absorption rather than gastric degradation.
Wound Debridement — Topical and Surgical Applications
Bromelain-based wound debridement (Debrisoft-NexoBrid in Europe) uses concentrated bromelain extract applied topically to selectively digest necrotic tissue and eschar in burns and chronic wounds. Industrial-grade pharmaceutical bromelain for wound care R&D requires high specific activity, controlled particle size for gel formulation, and full microbial safety testing. Our pharmaceutical-grade product at 2,400 GDU/g with full safety documentation supports wound care product development.
Digestive Enzyme Supplement Blends
Bromelain at 100–500 mg per capsule (600–2,400 GDU/g) is commonly included in broad-spectrum digestive enzyme supplements alongside protease, amylase, lipase, and cellulase. For this application, pharmaceutical-grade purity with low microbial count and heavy metal absence is required for US NSF-certified or EU GMP-compliant supplement production. Stability data in capsule matrices and compatibility with co-formulated enzymes should be verified.
Sinusitis and Respiratory Supplement Products
Clinical trials support bromelain at 500–1,000 mg/day in sinusitis and upper respiratory product formulations, where its anti-inflammatory and mucolytic properties may reduce nasal congestion and secretion viscosity. For liquid and syrup format supplements targeting this application, water-soluble bromelain with confirmed stability at pH 5.0–7.0 is preferred. Our pharmaceutical-grade bromelain dissolves cleanly in aqueous solution at pH 5.0–7.0 for direct-to-consumer liquid formulations.
| Parameter | Value |
| Activity range | 600 – 2,400 GDU/g (or 1,000,000 CDU/g) |
| Optimal pH | 5.0 – 8.0 |
| Optimal temperature | 40°C – 65°C |
| Form | Light yellow powder — pharmaceutical grade |
| Shelf life | 24 months (sealed, cool, dry place) |
| Packaging | 25 kg drums / 1 kg / 5 kg bags for pharma |
Perguntas Frequentes
What is the difference between GDU/g and CDU/g in bromelain activity specification?
GDU (gelatin digestion units) measures bromelain activity using gelatin as substrate under standardised conditions defined by the FCC (Food Chemicals Codex). CDU (casein digestion units) uses casein as substrate, which provides higher sensitivity for protease activity. The two units are not directly interchangeable due to different substrate specificities. A typical pharmaceutical-grade bromelain at 2,400 GDU/g is approximately equivalent to 1,000,000 CDU/g. Always specify which unit system your quality standard uses to ensure comparable activity between batches.
What documentation is provided for pharmaceutical and nutraceutical procurement?
Our pharmaceutical-grade bromelain documentation includes: COA with GDU/g activity, specific activity ratio, protein content, moisture, and pH; TDS covering stability, solubility, and formulation guidance; MSDS; ISO 9001 certificate; HALAL and KOSHER certificates; heavy metal testing (Pb, Cd, As, Hg per USP/EP limits); total aerobic plate count and pathogen absence; and country-of-origin documentation. For US supplement manufacturers, NSF-compatible quality data is available. For EU, full traceability to raw material source can be provided.
Is bromelain stable in capsule and tablet formulations?
Bromelain in dry powder form in capsules or tablets (without moisture) is generally stable for 24 months at room temperature (below 25°C) when stored sealed and away from light and humidity. It should not be co-formulated with strong oxidants, reducing agents, or heavy metals that could denature the cysteine active site. Compatibility with specific excipients (fillers, binders, coating polymers) should be confirmed through accelerated stability studies at 40°C/75% RH following ICH Q1A guidelines for supplement stability.
Can bromelain be used in enteric-coated products for systemic absorption?
Enteric coating is commonly used for bromelain products targeting systemic anti-inflammatory or proteolytic effects, because uncoated bromelain may be partially inactivated by gastric acid at pH below 3.0 before reaching the small intestine where absorption occurs. Standard enteric coating with Eudragit L100-55 or HPMC phthalate provides gastric protection and releases the enzyme at pH 5.5 in the duodenum. Bromelain enteric pellets or enteric-coated tablets are established pharmaceutical formats in German enzyme combination products.
Request Pharmaceutical-Grade Bromelain Samples
Conte sobre sua aplicação e volume. Enviaremos uma amostra grátis, COA e preços competitivos em até 24 horas.
Solicitar Cotação