Enteric-Coated Softgels Explained for Brand Owners

EUPHM operates a dedicated softgel line with in-line enteric coating. The coater handles batch sizes from 50,000 to 400,000 softgels. Coating thickness is controlled between 30 and 80 microns, which determines the lag time before release. We validate gastric resistance using USP <711> dissolution testing at pH 1.2 for 2 hours, followed by pH 6.8 buffer. Typical acid resistance exceeds 90% of active remaining intact after the acid stage.

Line capacity runs at 1.2 million softgels per day for standard fills. Enteric coating adds 4 to 6 hours per batch, which is reflected in the 20–35 working day production window. We run pilot batches as low as 500 units for stability and dissolution testing before you commit to a full run. Tooling for custom shapes is available when volumes exceed 10,000 units.

Three enteric polymers are common: cellulose acetate phthalate (CAP), polyvinyl acetate phthalate (PVAP), and methacrylic acid copolymers (Eudragit L100 or S100). CAP dissolves above pH 6.0 and suits general use. PVAP offers better moisture resistance for hygroscopic fills. Methacrylic copolymers give the tightest release profile and are preferred for probiotics and enzymes where you need delivery past pH 5.5.

The fill matrix matters as much as the coating. Oil-based fills are straightforward. Suspension fills with probiotics require low-temperature processing to protect viability. We test each formulation for 3 months accelerated stability at 40°C/75% RH and 6 months at 25°C/60% RH. Enteric coatings can add 10–15% to unit cost over a standard softgel, depending on polymer and batch size.

Every enteric-coated batch ships with a certificate of analysis covering appearance, fill weight, disintegration, and dissolution. We hold GMP, ISO 22000, and HACCP certifications. Halal, and vegan certifications are available when the formulation and coating polymer meet the relevant standards. Note that standard CAP is not vegan; vegan brands should specify a plant-derived polymer such as PVAP or a cellulose-based alternative.

We are an FDA-registered facility, which allows us to manufacture for the US market. Documentation for EU and Middle East buyers includes heavy metals testing, microbial limits, and allergen statements. Lead times for coated softgels are 20–35 working days for mass production, with 7–10 working days for samples. We recommend budgeting 2–3 weeks for label review and artwork approval alongside production.

Every enteric-coated softgel batch is tested at three stages: incoming raw materials, in-process coated shells, and finished goods. Identity and potency testing by HPLC or GC confirms active content within 90–110% of label claim. Microbial testing covers total aerobic count, yeast and mould, E. coli and Salmonella. Heavy metals (lead, cadmium, arsenic, mercury) are screened by ICP-MS against USP <232> limits. Disintegration testing follows USP <701> for enteric-coated articles: no breakdown in simulated gastric fluid for 2 hours, then complete disintegration in simulated intestinal fluid within 60 minutes.

A certificate of analysis (COA) is issued per batch and includes lot number, manufacture and expiry dates, specification limits, test methods, results and a pass/fail statement. Additional data such as coating weight gain (typically 3–8% of shell weight) and seam integrity are recorded. Retention samples of each batch are held for the full shelf life plus 12 months at controlled conditions. Stability protocols follow ICH Q1A(R2): 25°C/60% RH long-term, 30°C/65% RH intermediate, and 40°C/75% RH accelerated for 6 months, with disintegration and potency checked at 0, 3 and 6 months.

Documentation packages are available in English and can be tailored for EU or US audits. Batch records, equipment logs and deviation reports are retained for at least five years. If you require third-party testing at an external laboratory, we can arrange it at cost and include the report in the batch file. For enteric softgels, the coating polymer supplier's certificate of origin and food-grade declaration are also kept on file.

Enteric-coated softgels are hygroscopic and sensitive to moisture and heat, so packaging must provide a good moisture barrier. Common options include HDPE bottles with induction seals and desiccant sachets (30, 60, 90 or 120 count), blister packs with aluminium foil (PVC/PVDC or cold-form), stick packs for single-dose formats, and sachets for powder blends. Bottle sizes range from 50 mL to 500 mL. We can supply child-resistant closures and tamper-evident bands where required by market.

For US retail, labels must include the statement of identity, net quantity of contents, nutrition or supplement facts panel, ingredient list, allergen declarations, and the manufacturer or distributor address. Lot number and expiry date are inkjet-printed on the bottle and outer carton; we can also apply QR codes or DataMatrix codes for traceability. Amazon FNSKU labels, poly-bagged units and carton labelling to your specification are available. Cartons are typically 5-ply corrugated, with pallet configurations of 48–60 cartons per layer and up to 1,200 kg per pallet, stretch-wrapped and edge-protected.

We do not provide regulatory review of your label artwork, but we check that the lot and expiry fields are correctly placed and legible. For EU markets, the label must include the food business operator address and a best-before date. For halal certification, the certifying body's logo must be approved before printing. Retail-ready packaging, including shelf-ready trays and display cartons, can be quoted separately.

Sampling starts with a technical review of your formula and target dosage. Coated prototype samples are typically ready in 7–10 working days after receipt of actives and shell materials. If custom tooling is needed, add 10–15 working days for tooling fabrication and first-article approval. Sample costs are credited against the first mass-production order. Mass production runs 20–35 working days after sample approval and receipt of deposit, depending on coating complexity and packaging format.

Shipping options include air freight (5–10 days door-to-door) and sea freight (25–40 days port-to-port). We quote EXW, FOB Shenzhen or Hong Kong, and DDP for most destinations. For DDP, we handle export clearance, freight, import clearance and final delivery; duties and taxes are billed at cost. Air shipments are typically palletised and shrink-wrapped; sea shipments use fumigated or heat-treated pallets where required by the destination country.

Documents provided with each shipment include the commercial invoice, packing list, bill of lading or airway bill, certificate of analysis, material safety data sheet (MSDS) where applicable, and a free-sale certificate. For plant-based actives, a phytosanitary certificate can be arranged on request. We recommend confirming the import requirements of your destination country before production, as some markets require additional health certificates or prior registration.