The UK-based company taps into a market that has become increasingly popular within the pharmaceutical industry. Controlled release combination products present potential solutions to formulators and manufacturers such as physico-chemical and biological compatibility, process scale-up and packaging.
DuoCap is a drug delivery system in which a single oral dosage unit comprises a ‘capsule-in-a-capsule.’ Here, two independent compartments form one dosage unit that can target incompatible drugs to different regions of the body, for example the gastrointestinal tract.
The inner and outer capsule normally contains a liquid or semi-solid formulation with only the inner capsule able to house the more delicate powder formulation. The multi layer aspect of the structure means DuoCap can deliver sustained, pulsed or delayed release profiles for prescription and over-the-counter medicines.
"DuoCap was initially developed for use with probiotic treatments but now has huge potential for the delivery of many pharmaceutical active agents requiring controlled release,” said Robbie Stewart, sales and marketing director.
“Encap is able to manufacture DuoCap for clinical or proof-of-concept studies right through to full scale commercial volumes,” he added.
Solubility solution
Poorly soluble compounds and the resultant problems that arise in controlling their release have remained a source of frustration amongst drug manufacturers within the pharmaceutical industry.
However, specialist drug delivery firms have established liquid filling of hard shell or two piece capsules as a proven method of drug delivery, becoming one of the fastest growing sectors of the drug delivery market.
Its versatility in not only accommodating liquid but also semi-solid and wax-based formulations for improving bioavailability and stability for controlled release applications has seen the market increase at a rate of 30 per cent per annum.
The technology is all the more crucial given the number of highly potent chemical and biological-based drugs moving through development pipelines today, particularly for cancer treatments.
Approvals
The multi-stage nature of tablet’s make up has particular relevance to combination therapies that are currently of significant interest, demonstrated by the recent launches of GlaxoSmithKline’s Combodart and AstraZeneca’s Vimovo.
In May, AstraZeneca and Pozen announced the US Food and Drug Administration (FDA) has approved Vimovo delayed-release tablets for osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
Vimovo is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a proton pump inhibitor (PPI).
Likewise, Combodart has become the first single capsule, fixed-dose combination therapy to be approved in Europe for the treatment of moderate-to-severe symptoms of benign prostatic hyperplasia (BPH).