BioProgress has completed the design and build of the first pilot scale version of its XGEL NROBE powdered drug coating technology and will now deliver the machine to Farmasierra in Madrid, Spain.
Last month, BioProgress shipped the first systems for its XGEL TABWRAP, a non-gelatine coating for tablets based on the same film technology used in NROBE.
Intended as an alternative to gelatine-based coatings, BioProgress's NROBE is a low cost process that enables tablets to be wrapped in soluble, cellulose-based films that can be modified to meet specific dissolution and stability requirements. They can also be produced in virtually any colour or two-colour combination and pre-printed with brand names.
Farmasierra said it will now commence a programme of new product development and comparative studies to generate data that shows the benefits of the NROBE technology in improving release characteristics and drug performance when compared with standard dosage forms.
Dr Tomas Olleros, president and CEO of Farmasierra, said: "The delivery of the pilot scale machine will enable us to broaden our development programme. The NROBE technology opens up the possibility of significant formulation improvements to existing pharmaceutical products and the formulation of new products with enhanced active delivery performance."
NROBE also streamlines the manufacturing process by eliminating several stages required in traditional tablet dosage form production, he added.
Coating is now standard practice for solid dosage forms in prescription and OTC (over-the-counter) pharmaceuticals in part because it enhances shelf life but also because research shows that consumers prefer to swallow a coated rather than an uncoated tablet. The coating colour also enables strong product and brand identity, according to BioProgress.
High volume, automated tablet coating systems are certainly available, but they require multi-million dollar investments - and expensive modifications if solvent-based drying is used. In addition, coating must be carried out in a time-consuming batch process, rather than continuous in-line production. And there must be complete product inspection, rather than random inspection, BioProgress points out, as a percentage of each batch will have been chipped or damaged during the tumbling process used in spray coating.
The gelatine enrobing process uses gelatine films with high water content requiring tablets to be pre-coated prior to enrobing, and additional costs, time and product stress is incurred as in some cases tablet cores must be shipped to a gelatine plant to be enrobed and then shipped back to the tablet core manufacturer.
Meanwhile, BioProgress has unveiled two additional partnerships. The first is the second phase of an agreement that has been running for nearly a year and involves the transfer of a major global product into the XGEL technology. The second is a new development agreement with another major top 10 pharmaceutical company working with BioProgress for the first time.