Delayed-Release Capsule Manufacturer

Our encapsulation suite includes 12 automatic capsule filling machines with a combined output of 1.8 million capsules per day. For delayed-release formats, we use fluid-bed coating systems with precise temperature and spray-rate control. This allows uniform film thickness across batches from 1,000 to 500,000 units. We monitor coating weight gain in real time and verify enteric integrity with disintegration testing in simulated gastric fluid for 2 hours, followed by intestinal fluid.

We handle both gelatin and HPMC (vegetarian) capsule shells. For clients targeting halal markets, we source certified empty capsules and maintain segregated production runs. Our team can also work with your existing formulation or develop a coating protocol from scratch. All processes are documented for tech transfer and regulatory submission.

Delayed release is critical for ingredients that degrade in stomach acid, including probiotics, enzymes, omega-3s, and certain plant extracts. We select the coating polymer based on your target pH and transit time. For example, Eudragit L100-55 dissolves at pH 5.5, while Eudragit S100 targets pH 7.0. This ensures release in the duodenum or ileum, depending on your needs.

We also evaluate fill compatibility. Some actives interact with coating solvents or require a subcoat to prevent migration. Our formulation team runs accelerated stability studies at 40°C/75% RH for 3 months to confirm that the delayed-release profile holds over shelf life. If needed, we adjust plasticiser levels or add a seal coat. Every batch is tested for assay, dissolution, and moisture content before release.

EUPHM operates a GMP-certified facility with ISO 22000 and HACCP accreditation. Our quality unit reviews every batch record, and we retain samples for 12 months after expiry. For delayed-release capsules, we perform USP <711> dissolution testing at multiple time points. We also offer halal and vegan certification for applicable projects. Third-party lab testing is available on request.

We ship worldwide from Guangdong, China. Standard packaging is HDPE bottles with induction seals, or blister packs for unit-dose formats. Air freight to the US or EU takes 5-8 days; sea freight 18-25 days. We provide all export documents, including Certificate of Analysis, MSDS, and health certificates. For repeat orders, we hold your approved formulation and artwork for 24 months.

Every delayed-release capsule batch is tested against a written specification before release. Incoming raw materials are sampled at √n+1 per container and tested for identity by FTIR, assay by HPLC, microbial limits (TPC, yeast and mould, E. coli, Salmonella), heavy metals by ICP-MS (lead, cadmium, arsenic, mercury), and, where relevant, residual solvents by GC. Excipients and capsule shells are checked for appearance, dimensions and moisture content. Water used in coating preparation meets pharmacopoeial purified water standards and is monitored weekly.

In-process checks run at defined intervals during encapsulation and coating. Capsule fill weight is verified every 15 minutes on a 10-capsule sample, with acceptance limits of ±5% of target for fills above 300 mg and ±7.5% below. Coating weight gain is measured on 20 capsules per pan at start, middle and end, targeting 8–12% w/w depending on the enteric polymer. Disintegration testing in 0.1 N HCl for 2 hours followed by pH 6.8 buffer is performed on each coating pan; capsules must remain intact in acid and disintegrate within 60 minutes in buffer. Dissolution profiling (USP Apparatus 1 or 2) is run on finished batches at 1, 2, 4 and 6 hours to confirm the release curve matches the approved target.

Finished-product testing includes assay and uniformity of dosage units by HPLC, microbial limits, heavy metals, and where applicable residual moisture (Karl Fischer, target below 6% for HPMC-AS coatings). A Certificate of Analysis (COA) is issued per batch and includes: product name, lot number, manufacture and expiry dates, specification references, test methods, results with pass/fail against limits, and the signature of the QC manager. COAs are available in PDF within 48 hours of batch release. For US-bound products we can include a statement of conformity to 21 CFR 111 cGMP requirements; for EU-bound products, a statement of compliance with EU GMP Annex 1 where applicable.

Retention samples of every batch are stored at 25°C/60% RH and 30°C/65% RH for the full shelf life plus 12 months. Stability protocols follow ICH Q1A(R2): long-term (25°C/60% RH), intermediate (30°C/65% RH) and accelerated (40°C/75% RH) conditions, with testing at 0, 3, 6, 9, 12, 18 and 24 months for long-term and 0, 3 and 6 months for accelerated. Parameters include appearance, assay, disintegration, dissolution and microbial limits. Stability data packages are shared with clients under confidentiality; ongoing stability is maintained for each commercial product. Batch records are retained for five years after expiry.

We offer primary packaging in HDPE bottles (30, 60, 90, 120, 180 and 250 cc) with induction seals and child-resistant or standard caps, blisters (PVC/PVDC or alu-alu for moisture-sensitive formulas), stick packs and sachets. Bottle filling lines run at 60–120 bottles per minute and include desiccant options (silica gel canisters or sachets) where the stability profile requires it. Blister lines handle 10, 12, 14, 20 and 30-count formats. For stick packs, fill weights range from 1 g to 5 g, with a four-side seal and tear notch. All primary packaging materials are food-grade and supplied with certificates of conformity.

Labels for the US market include all FDA dietary-supplement label elements: statement of identity, net quantity of contents, supplement facts panel with serving size and percent daily value where applicable, list of ingredients by common name, allergen declarations (e.g. contains gelatin), and the name and place of business of the manufacturer, packer or distributor. We can add the DSHEA disclaimer if requested. For EU retail, labels include the nutrition declaration, recommended daily portion, storage conditions, batch code and best-before date, and the name and address of the food business operator. We do not print health claims without client-supplied substantiation.

Lot coding follows a client-defined format or our standard Julian date plus line code. Expiry dates are calculated from stability data and printed in the format requested (MM/YYYY or DD/MM/YYYY). Cartons are printed with product name, lot, quantity, dimensions and gross/net weight; pallets are configured to client specification, typically 1,200 x 1,000 mm or 1,200 x 800 mm, with a maximum height of 1,800 mm including pallet, and stretch-wrapped. We can apply Amazon FNSKU labels, polybag the bottles with a suffocation warning, and pack in Amazon-ready master cartons with the required carton labels. Retail compliance checks (e.g. GS1 barcodes, country of origin marking) are performed before shipment.

Sample requests are handled within 7–10 working days from receipt of a signed sample request form and, where a custom formulation is involved, a mutually agreed specification. Samples are supplied free of charge for standard formulas; client-specific coatings or fills may incur a development fee, credited against the first production order. The sample pack includes a preliminary COA, a specification sheet and a packaging mock-up where relevant. We recommend that clients test samples for appearance, disintegration and dissolution before approving mass production.

Mass production lead time is 20–35 working days after approval of the sample, artwork and purchase order. This window covers raw material procurement (7–10 days for standard enteric polymers), encapsulation and coating (5–10 days depending on batch size), QC testing and release (3–5 days), and packaging (2–5 days). Delays can occur if artwork approval or label supply is late; we provide a production schedule at order confirmation and weekly progress updates. For repeat orders with unchanged specifications, lead time can reduce to 15–25 working days.

Shipping is arranged by air or sea depending on volume and urgency. Air freight (typically 3–7 days door-to-door) suits pilot batches and small retail orders; sea freight (25–40 days to US or EU ports) is more economical for full pallets. We quote on EXW, FOB Shenzhen or Hong Kong, and DDP terms; DDP includes customs clearance and delivery to a named address, with duties and taxes paid by us and recharged at cost. All shipments include a commercial invoice, packing list, bill of lading or airway bill, COA, MSDS (where required for transport), and a free-sale certificate. For plant-derived ingredients we can provide a phytosanitary certificate where the destination country requires it. We do not arrange product liability insurance unless requested; clients should confirm their own cover.