Active pharmaceutical ingredients (API)

from development to production

The particle size is an important parameter in the development and manufacture of pharmaceutical products. Micronisation serves to significantly improve the dissolution rate of active pharmaceutical ingredients (API). In the case of inhalers (DPI – dry powder inhalers), the particle size of the active ingredients and carriers is a decisive, quality-determining property in the formulation of the dry powder. The optimal particle size ensures the transport of the medicine into the lungs and also its effectiveness.

Flexibility is required with respect to the different fineness values and products. Furthermore, varying batch sizes often call for different handling concepts.

The process transfer is a special challenge: whether it be from development to production scale regardless of the location, or to a toll manufacturer.

The quality is always paramount in the manufacture of pharmaceuticals, achieved through reliable, reproducible and well-documented processes.

Whether continuous production or batch mode, the construction materials, surfaces, the automation and documentation of production systems for pharmaceuticals are all prepared according to cGMP design criteria.

A solution for manifold challenges

Quality begins as early as the planning and project phase. An individual system concept is prepared to match the user requirement specification (URS). A wide range of different technologies from preliminary crushing to fine grinding and micronisation can be chosen from.

The aim is to achieve an optimum grinding process.
Typical quality-determining features are:

  • Product- and process-gas-contact parts in AISI 316L
  • Surface roughness standard Ra < 0.8 µm (dependent on the product Ra < 0.4 or Ra < 0.25 with/without eletropolishing)
  • Seals and filter materials are food- and drug-grade quality as defined in FDA 21CFR177.2600
  • The pharma bearing concept includes a clear separation between drive and process, thus the end product contains neither particles nor oil
  • Encapsulated, permanently lubricated bearing or the use of USDA-H1 grease
  • Fully CIP/SIP-capable machines thanks to the patented Pharmaplex® bearing concept
  • Largely monobloc components with a minimum of welds and seals
  • Design free from dead spaces
  • Drainage and venting points for complete emptying with CIP/SIP-capable systems
  • Controls as defined in GAMP 5 and 21 CFR Part 11
     

Increasingly important is to ensure the flexibility and thus to make the systems obsolescence-proof. The multi-mill system concept is a tried-and-tested approach in order to produce different products, fineness values and batch sizes.

     

  • Design free from dead spaces
  • Easy to dismantle and clean
  • High production quality
  • Modern automation concepts
  • Manufacture in monobloc design
  • Validation documents
Product End-product fineness Throughput kg/h Machine size
Acemetacin 99 % < 32 µm; 50 % < 8 190 200 ZPS
Acyclovir 97 % < 28 µm 20 140 AFG
Amoxicillin 99 % < 18 µm; 50 % < 6 9 50 ZPS
Bisphenol A 99 % < 63 µm 370 40 ACM
Carbamazepine 86 % < 8 µm 2 100 AFG
Cholestyramine 99 % < 7.5 µm 0,3 100 AFG
Celecoxib 90 % < 23 µm 33 200 AS
Cilostazol 99 % < 10 µm 4 100 AFG
Cimetidine 99 % < 32 µm 11 100 AFG
Dextromethorphan 97 % < 5 µm 0,5 50 AS
Flutrimazole 97 % < 38 µm; 50 % < 4,4 5 50 ZPS
Lactose 97 % < 25 µm; 50 % < 8 20 - 25 50 ZPS
Lactose 99 % < 30 µm 137 10 ACM
Lactose 97 % > 8.9 mm 16 200 AS
Lactose 99 % < 5 µm 1 100 AS
Lactose 95 % < 6 µm 39 200 AFG
Lactose 98 % < 10 µm 100 400 AFG
Metformin 99 % < 150 µm 480 400 AFG
Naftidrofuryl 90 % < 19.6 µm; 50 % < 7.4 45 100 ZPS
Nifedipine 97 % < 45 µm; 50 % < 17.9 125 200 ZPS
Nifedipine 90 % < 2.4 µm 32 500 AS
Nifedipine 97 % < 3.8 µm 2,7 100 AS
Nifedipine 98 % < 96 µm 23 100 AFG
Omeprazole 97 % < 4.1 µm 0,8 100 AS
Omeprazole 98 % < 7.5 µm 10 200 AFG
Oxytetracycline 99 % < 25 µm 50 140 AFG
Pharma polymer 90 % < 50 µm 2 100 AFG
Piroxicam 99 % < 61 µm 30 50 ZPS
Piroxicam 99,9 % < 15 µm 3,2 50 ZPS
Progesterones 99 % < 14 µm 20 200 AS
Salbutamol 97 % < 5.2 µm 4 100 AS
Salbutamol sulphate 97 % < 9 µm 4 100 AFG
Simvastatin 90 % < 10 µm 3 100 AFG
Sodium ascorbate 99 % < 130 µm; 50 % < 19 140 100 ZPS
Sodium chloride 99 % < 4 µm 10 200 AFG
Sorbitol 99 % < 300 µm 230 10 ACM
Tartaric acid 99 % < 100 µm 100 10 ACM
Theophylline 99 % < 87 µm 170 300 ZPS
Ticlopidine 99 % < 30 µm 13 100 AFG
Vitamin B2 99 % < 50 µm 25 200 AS
Vitamin B2 99 % < 5 µm 12 200 AFG
Zaltoprofen 90 % < 9 mm 4 100 AS
Typical examples of ground active ingredients (API).
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Brochure Respiratory Drugs
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Brochure Pharmaceutical Technology - GMP
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