EUROPE’S LEADING CONTRACT MANUFACTURER FOR LIQUID FILLED HGC
Tillotts specialises in the manufacture of liquid filled, hard gelatine capsules. In 25 years of successful partnership with “big- and small Pharma” Tillotts has produced over 1 billion liquid and paste filled hard gelatine capsules (“HGC”). Tillotts has an excellent reputation for being a reliable, first class supplier, gained over many years.
Tillotts Manufacturing services:
Tillotts is expanding its capabilities to include contract development services to complement its established track record in commercial liquid-fill encapsulation, built up over a quarter of a century. The new Tillotts Manufacturing Services will include a broader service offering to the global pharmaceutical and nutraceutical industries covering;
Oral Drug Delivery solutions; primarily in the gastro intestinal area where we have a demonstrated capability through the development and manufacture of novel, global products such as Colpermin.
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Contract Research and Development; helping clients chose the appropriate oral capsule formulation and supplying finished clinical development product from pre-clinical to commercial manufacture.
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Commercial liquid-fill manufacturing; our long-established capabilities cover full service provision for the global supply of liquid-filled capsules, packaging and finished drug product supply.
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Regulatory Support; we support our clients in areas of validation, method development, ICH stability and regulatory support.
Why liquid filled HGC?
A wide range of materials can be filled including natural oil products, suspensions of drugs in oil and low melting point (<60°C) waxes. It has been found that the absorption of poorly or erratically absorbed drugs can often be enhanced by formulating a solution or suspension in lipophilic carriers, giving a wide application to this dosage form.
Capsules are normally banded after filling to seal the two halves together in order to prevent leakage. The capsules can be coated with time-release or enteric polymer coatings using aqueous and organic-based systems.
Instead of hard gelatine capsules (HGC), also Hydroxy Propyl Methyl Cellulose (HPMC) capsules can be filled and sealed.
Advantages over soft gelatine capsules:
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Ability to include a higher solid content
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Use of elevated filling temperatures allowing incorporation of waxy materials
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Will disintegrate faster due to the capsule wall being five times thinner than the wall of soft gelatine capsules
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Lower weight of capsule as compared to soft gelatine formulations
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Reformulation from tablet, powder-filled capsules or soft gelatine capsules to liquid-filled hard gelatine capsules as part of product life cycle management
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A wide range of colours are available for hard gelatine capsules to ensure product identification and brand recognition
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Low dose products possible to manufacture (uniformity of contents)
Manufacturing Equipment:
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2 liquid filling/banding (Bosch/Shionogi) lines in dedicated rooms
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1 liquid filling equipment (Bosch) for small quantities or pilot batches
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Lab-scale band-sealing equipment
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Capacity of 200 m capsules per annum
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Liquids or semi-liquids from 0.25 ml up to a maximum of 0.80 ml can be filled in the hard gelatine capsules (capsule sizes 3 to 00)
Packaging Equipment:
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Blister packer/cartoning line with capacity of 200 m capsules per annum
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Pack bundling equipment
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Possibility to apply Data Matrix code on the finished pack
Analytical Equipment:
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Disintegration & Dissolution equipment
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HPLC
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GC
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IR
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UV/VIS
Development Services:
Having manufactured liquid filled HGC for more than 25 years we have gained an in-depth knowledge in this technology. Tillotts can assist your company with the formulation of new products. We can run feasibility trials and produce batches for stability testing or for use in clinical trials supported by full GMP documentation. Scale up to production can be performed including process validation.
GMP approved facilities:
Tillotts production facility is regularly inspected by the Swiss Authorities (SwissMedic) and also frequently by major Pharma clients and meets EU GMP requirements.
Enquiries regarding our services should be directed to:
Claudio Scialdone
Contract Manufacturing Manager
Phone: +41 61 935 2840
Mobile: +41 79 252 3803
Fax: +41 61 935 2880
e-mail: cscialdone@tillotts.com
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