Nemera is a world leader in design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generic industries, including complex dermal drug delivery devices.
Dermal pharmaceuticals, cosmetics and personal hygiene products all use the skin as their point of access, but there is a world of difference between how they are each regulated or manufactured.
For pharmaceutical applications, the dispensers need to be suitable to contain drug formulations and ensure that the treatment delivery to the patient is consistent. Very few are able to fulfill these requirements. They can be identified by their compliance to regulatory standards specific to packaging of medicinal products and to medical devices.
“This is essential to ensure that both the formulation and its container are safe and easy to use for patients”, confirms Raphaële Audibert, Nemera’s Global Category Manager for dermal pharmaceutical devices.
Some dermal delivery devices are even airless which ensures the formulation not to be in contact with air.
“Some of the treatments – the formulations – they contain are very sensitive and need to be perfectly protected to remain stable” she said. When you press down on the pump of, say, a soap dispenser, you have air that goes in the bottle when the product comes out, but that does not happen with airless devices.
This allows the pharma company to avoid overfilling as most of the formulation is extracted from the device and the patients to use the device in any position. Depending on the application site on the body this last function can simplify treatment administration. The skin is used in pharmaceutical delivery to target three areas.
The first, and most common, are the upper layers of the skin itself used to treat dermatological conditions such as acne, atopic dermatitis or psoriasis.
The second is the bloodstream, referred to as ‘transdermal systemic delivery’, whereby gels or creams are absorbed and circulated into the whole body by the bloodstream.
The main examples are hormone replacement therapy, or HRT, for women with menopausal symptoms or for men having hypogonadism.
And the third are the underlying tissues below the skin layers, referring to the application of anti-inflammatory treatments directly to the source of the problem, most commonly aching knee, elbow and shoulder joints. Here, the drug is absorbed through the skin into the muscles and tendons below.
Nemera has been working in the dermal field for the past two decades and produces airless devices used by some of the biggest pharmaceutical companies in the world to ultimately serve patients’ needs, and is today leading the systemic transdermal gel and cream market.
The first treatment launched with a Nemera device was for cold sores, and today millions of patients rely on its precise delivery systems for a wide range of topical and systemic conditions in the dermal drug delivery field alone.
One of the biggest breakthroughs has been the airless device designed by the Nemera team, Sof’Bag®.
Sof’Bag® is composed of an aluminium based pouch inside a bottle surrounded by a metered pump dispenser. It is designed with several features: the part containing the formulation, the pouch, protects it from oxidation, light and humidity. These elements can sometimes alter the formulation and modify its efficacy if they are allowed.
With 360° delivery thanks to its airless property, the Sof’Bag® can also dispense formulation across a wide range of viscosities, whether liquid, oil, cream or ointment increasing patients’ convenience. Very little of the product
is wasted– more than 95% of the contents of this ‘pouch-in-a-bottle’ can be extracted. Goes without saying that we comply to the regulations. For instance, the ISO 15378 and ISO 13485 standards among others.
Audrey Chandra, Category Manager said: “We focus on addressing patients’ needs by developing and producing high-end devices as well as on giving the pharmaceutical companies all the technical support they might need along the way.”
Nemera provides an end-to-end service, which includes taking a product from early-stages concept, including human factors studies, to design and high scale manufacturing, the technical support needed in relation to filling the drug delivery devices, and supporting the submission of registration dossiers to the appropriate regulatory authorities.
This holistic approach and integrated front-to-end services enable Nemera to innovate within every development phase of its products. Our ultimate goal is to foster patients’ adherence to their treatment and improve their quality of life.