We have 30 years of experience in the development of products using our oral drug delivery technologies and expertise. We provide a comprehensive range of development services from feasibility studies to full formulation development and scale-up of complex oral formulations, designed to meet a wide range of delivery profiles and using proven technologies. We can apply a broad range of proprietary technologies to develop a specific target product profile and provide additional product protection, and to support your life cycle management strategy.

A multinational team of highly experienced and motivated scientists use our proprietary technologies to develop multiple complex oral dosage forms which are currently marketed by our international partner companies in numerous countries worldwide including the US and Japan and in Europe. There are still many unsolved challenges in the oral drug delivery field and we continue to use our longstanding expertise to conceive innovative drug delivery systems to overcome them.

 

CapabilitiesSkyepharmaPartner
Drug discovery and API manufacture   skye-dot.png 
Formulation development skye-dot.png   
Analytical development skye-dot.png   
Process development skye-dot.png   
Manufacturing of clinical trial materials skye-dot.png   
Scale-up and technology transfer skye-dot.png   
Project management skye-dot.png  skye-dot.png 
Regulatory affairs skye-dot.png  skye-dot.png 
Commercial manufacturing* skye-dot.png   
Sales and marketing   skye-dot.png 

* in conjunction with CMOs.

Scale up and manufacture

Our oral drug delivery services include the manufacture of clinical materials and scale-up technology transfers.

Manufacturing of clinical train materials

We use GMP facilities to manufacture batches of development products that can be used for clinical trials to support the validation of the product concept and for the later approval process.

Scale-up and technology transfers

We are experienced with scale-up of complex dosage forms from laboratory to pilot-scale and full commercial scale manufacturing, having performed these tasks for numerous developments and commercial products.

Commercial manufacturing

Through our partnerships with third-party CMOs we can provide commercial manufacturing for products that incorporate our drug delivery technologies.

Regulatory support and project management

Our oral drug delivery services include regulatory support and project management, to maximise the probability of approval of the product that we develop.

Regulatory affairs

We have a long track record of supporting regulatory approvals for oral modified release products in international markets including the US, Europe and many other countries. We regularly support our customers in compiling their dossiers and provide advice on submission and product maintenance processes.

Project management

Our project managers are experienced in the coordination of development resources and activities as part of an integrated team with our partners and suppliers. They are skilled in managing complex oral product development programmes, and provide a single- point of contact with our partners to ensure rapid and efficient communications. This helps to ensure that projects are delivered on time and on budget, and that our partners are fully informed of progress.

Working in partnership

We have many years’ experience of working with our partners in the development and manufacturing of complex oral dosage forms, including as part of a planned life cycle management strategy. This has resulted in ten different oral products that are currently marketed by multinational pharmaceutical companies in numerous countries worldwide.

Our highly experienced team of specialists can work with you to optimise your target product profile and your drug development programme from early formulation development, scale-up and manufacturing to regulatory support, to maximise the chances of your product reaching the market.

Pharmaceutical life cycle management

We have a long track record in pharmaceutical Life Cycle Management, having successfully created value for many drugs by applying its proprietary technologies to offer improved efficacy, use lower doses or provide improved side-effect profiles, whilst also offering additional proprietary protection for originators. In many cases it was only the application of our technologies and know-how that enabled the existing drug to be repositioned to fulfil an unmet medical need.

The challenge

Life Cycle Management is no longer just about reformulation of existing drugs with only incremental performance improvements. In the current climate of evidence-based medicine and cost containment, physicians and payers demand significant enhancements in performance or the answer to unmet medical needs in order to justify prescription or reimbursement.

Application of technologies to improve performance

We have successfully applied our technologies to the formulation of a number of products, allowing them to be repositioned to offer improved clinical performance over existing treatments. These products are currently sold by major pharmaceutical companies in more than 80 countries including the US, Europe and Japan. Some examples are listed in the table below:

Life Cycle Management Objective

Technology

Product examples

Repositioning of established drugs by synchronizing pharmaceutical delivery with therapeutic need

Geoclock™

RAYOS® / LODOTRA®
SKP-1041 
SKP-1052

Improved dose regime and an aid to patient adherence

Geomatrix™

Paxil CR™ 
Requip® Once-a-day 
Coruno®

Improved dose regime by combining several different drug release rates in a single tablet

Geomatrix™

Diclofenac-ratiopharm® uno 
Zyflo CR®

Improved dose regime by enhancement of absorption of drug in the lower gastrointestinal tract

Geomatrix™

Sular®

Improved dose regime by enhancement of bioavailability and reduction of food effect

IDD®DissoCubes™

 Triglide®

Chronotherapy: application in pharmaceutical life cycle management

We have applied the concept of chronotherapy to support life cycle management. The following case study provides just one example of how we have applied our proprietary technologies to an established molecule to develop an innovative product whilst offering proprietary protection for the originator.

Case study 1

Repositioning of an established rheumatoid arthritis drug by synchronising pharmaceutical delivery with therapeutic need.

The challenge

Many patients with rheumatoid arthritis (RA) experience morning stiffness, the duration of which is strongly associated with functional disability, pain and general patient health1. The duration of morning stiffness has been identified as the second-leading predictor for change of disease modifying drugs or biologic therapy2. Prednisone is an established treatment for RA, but the traditional regime of morning administration does not mediate the nocturnal cytokine peak3, so patients experience stiffness and pain for many hours after treatment.

Cytokine-pain-graph.jpg

The solution

We formulated the RA drug prednisone using our Geoclock™ chronotherapy so that the active drug is released with a lag-time of four hours after bed time dosing4 in order to coincide with the night time cytokine peak, and so reduce early morning stiffness5.

Rayos-cytokine-pain-graph.jpg

The repositioned product, which is known as LODOTRA® in Europe and RAYOS® in the US, is marketed by Horizon Pharma and has been granted a premium price and reimbursement.

1. Kahn, NA, et al. J Rheumatol. 2009; 36; 2435-2442.
2. Soubrier, M. et al. J Rheumatol. 2006 Jul; 33(7):1243-1246.
3. Cutolo M et al, Ann Rheum Dis. 2003; 62:593-596.
4. Weaver A et al, Rheumatoloy Practice News, November 2012.
5. Buttgereit F et al, Lancet 2008; 371: 205-14.

Application of technology to provide patient benefits in pharmaceutical life cycle management

We have used the application of technology to support life cycle management. The following case study provides just one example of how we have applied our proprietary technologies to an established drug to develop an innovative product whilst offering proprietary protection for the originator.

Case Study 2

Reformulation of an established Parkinson’s disease drug to improve efficacy and reduce side effects

The challenge

Immediate-release ropinirole formulations require extensive titration to find an efficacious dose¹ whilst minimising dopaminergic side effects.  Due to the short half-life of ropinirole immediate-release formulations must be taken three times a day, and this can be a burden for Parkinson’s patients who are typically on multiple medications.

The solution

We formulated ropinerole to create Requip® Once a day using its Geomatrix™ technology. The product was designed to provide a smoother delivery of the drug over a 24-hour period, avoiding the peaks and troughs that multiple daily doses typically deliver², and to provide a continuous stimulation of dopamine receptors. Once a day formulations generally lead to better patient adherence. 

Geoclock.jpg

The product is approved in more than 40 countries, including the US where it was the first once-a-day oral ergot dopamine agonist indicated for Parkinson’s disease. It was approved in Japan in 2012 as one of the first once-a-day treatments for Parkinson’s disease. It is marketed by GlaxoSmithKline.

1. Handbook of Parkinson’s Disease, Fourth Edition, Pahwa, Lyons & Koller, CRC Press, 2012; p.356 Weaver A et al, Rheumatoloy Practice News, November 2012.
2. Thompson D et al, Clinical Therapeutics 2007; 29 (12): 2654-2666.

 

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