• MUD (Multiple-Unit Dosage Form)
• SUD (Single-Unit Dosage Form)

Pancreatin-containing bulk actives and medicinal products

We supply a wide variety of processed pancreatin bulk products as well as finished medicinal products and can supply each customer with tailor-made solutions to meet specific product requirements and production structures.

For example, we provide bulk pancreatin and add substances in line with the specific customer's formulation to produce a mixture ready for tabletting. We also provide pancreatin in the form of enteric coated microtablets and pellets which we can process to a finished medicinal product.
The prepared modules in the form of microtablets and pancreatin pellets are an ideal, low-cost starting point for reformulating conventional pancreatin single unit dosage forms or switching from matrix pellets to pellets with a pancreatin-only core.

Each customer can take full advantage of our specialist know-how. For example, we use enzyme-sparing environmentally benign methods and processes involving no organic solvents and provide full pharmaceutical and regulatory support. We guarantee our customers a top quality customized product manufactured using optimized production methods.

We have built up an extensive store of regulatory documentation in the course of our many years of experience with pancreatin and pancreatin products, including a European Drug Master File for pancreatin which is available upon request.

 

MUD (Multi-Unit-Dose-Form)

Enteric coated pellets

Unlike conventional pellets, our pancreatin pellet cores contain no added excipients and are 100% active drug.
This pellet core is manufactured in a special process which is fully integrated in the pancreatin production process, so there is no need for the high-cost manufacturing steps associated with conventional matrix pelleting.

Enteric coating is done in a solvent-free polymethacrylic acid/ester process using a dispersion film former. The specially developed fluidized bed drying process ideally provides the protection the enzymes require, owing to its excellent drying properties in the presence of mild temperature conditions. The coated pellets have a standard 1.4 - 2.4 mm mesh size sieve fraction. Other sieve fractions are available by special request.

Direct processing means there is virtually no loss of activity during the pelleting process. The gentle processing and use of pure undiluted active substance results in a pancreatin product with a high specific activity and enables the manufacture of high-dosed pancreatin drug products in a fairly small capsule size that is easy to swallow.

 

The typical quantity of fill per capsule for coated pancreatin pellets is:

 

 

SUD (Single-Unit-Dose-Form)

Pancreatin film-coated tablets

Nordmark also supplies pancreatin in a film-coated tablet formulation. The tablet cores are approximately 70 % pancreatin and contain standard pharmaceutical excipients. They are manufactured by a direct tabletting process and thus have all the advantageous described for the manufacture of film-coated microtablets.

Coating is done in a solvent-free process with a polymethacrylic acid/ester-based dispersion film. The specially developed tumble coating process with optimum drying properties in the presence of mild temperature conditions ensures that the enzymes get the protection they need. The coating is acid-fast pursuant to PhEur (2.9.1.).

Contract manufacture of film-coated and sugar-coated tablets

Nordmark meets all the criteria for a contract manufacturer of first choice: the company has the technology for manufacturing single unit dose forms of pancreatin (film-coated and sugar-coated tablets), the facilities to process organic solvents, the analytical and regulatory know-how.

Typical physical attributes for pancreatin film-coated tablets are: