Convenient, high integrity packaging solutions for the safe delivery of drug products

Illnesses and ailments associated with impaired function of the respiratory system are a major healthcare issue. They range from chronic obstructive pulmonary disease (COPD) and asthma to rhinitis, allergies and the coughs and cold that plague every day life. Estimates suggest that adults have around 2 – 3 colds per year on average and drugs for coughs and colds, along with those for allergies/hayfever account for a large portion of the over-the-counter (OTC) market.

Therapies for respiratory illnesses are often delivered directly to the site of action. For example, nasal drug products, typically nasal sprays, deposit droplets in the nasal cavity and are often a first line defence for ailments such as rhinitis and hayfever; throat sprays offer topical relief for localised soreness. Other orally delivered products include tablets and capsules and cough syrups, both of which are prevalent in the OTC marketplace. Traditional actives ingredients for cough syrups include for example ambroxol, carbocisteine or oxomemazine molecules. However, there is a growing trend towards natural/organic/herbal based cough syrups including herbal such as hedera helix, food such as honey or essential oils such as eucalyptus or tea tree. More generally essential oils are used to treat a range of respiratory conditions. For example, in France, the relief of respiratory-related symptoms accounts for almost 50% of essential oil usage*. Parenteral delivery (through passive diffusion or with a fogger) represents around 12% by volume of the respiratory market and is important for formulations that cannot be delivered via oral products**.

Glass is a popular packaging option for respiratory therapies, notably for nasal drug products, syrups, sprays and essential oils. It offers:

• Good UV protection, for light sensitive formulations
• A high level of chemical stability
• Flexibility, a wide range of solutions are available with numerous options for filling and sealing.

SGD Pharma’s portfolio for respiratory therapies includes bottles for nasal sprays, syrup bottles and dropper bottles and parenteral vials, in both clear and amber glass. The U-Save range is designed specifically for nasal applications and consists of bottles from 1 to 5 ml in volume, made exclusively from Type I glass, for maximum hydrolytic resistance. These bottles are designed to guarantee complete liquid delivery, to minimise drug wastage and are available in a range of neck finishes, to ensure an optimal match with specific dispensing systems. Type III glass products are a cost-effective option for syrups and droppers and the portfolio includes designs in a wide range of volumes, in both clear and amber glass.

* France Agrimer/Open Health, January 2018

** France Agrimer/Open Health, January 2018

Inert, easy-to-use packaging for the solutions that enhance diagnostic medicine

Chemical solutions – diagnostic agents and contrast media - are essential for effective pathology and play a crucial role in facilitating and enhancing the diagnostic medicine that underpins effective healthcare. Diagnostic agents, dyes or chemical reactants with high specificity, are used to detect and elucidate abnormalities in tissues and organs. Contrast media, on the other hand, are used with techniques including Computed Tomography (CT), Magnetic Resonance Imaging (MRI), X-ray and Ultrasound and extensively within Cath Labs (which focus on examinations of the heart and associated arteries). By improving image clarity and delineating specific features of an organ they enable the detailed study of tissues and organs, directly supporting more robust decision making throughout the patient journey.

Focusing on contrast media, classifying consumption by application identifies three significant areas of use:

• MRI agents – typically gadolinium-based products that improve the visibility of inflammation, blood vessels, tumours and in some cases blood supply to enhance the accuracy and clarity of MRI scans.
• Gasteroenterography agents – usually barium-based solutions that facilitate examination of the gastrointestinal tract.
• Angio-urography agents – predominantly iodated products for the detailed examination of blood vessels, the blood supply to vital organs such as the kidney, and the urinary system.

Many contrast media are delivered parenterally though the oral route is also routinely used, notably for gasteroenterography agents. Molded glass vials and bottles are a popular packaging choice offering:

• Chemical stability, glass is the most inert type of packaging and compatible with a wide range of different solutions
• Mature technology for filling, labeling and sealing
• Widespread availability and familiarity.

SGD Pharma provides a comprehensive range of products for contrast media including extensive choice in the 8 – 1000ml range most suitable for many of these products. The range includes Type I and II packaging, allowing every supplier to select a robust, cost-efficient solution closely tailored to the requirements of specific contrast media products.

All glass packaging is associated with excellent sustainability, due to well-established options for re-use, recycling and disposal.

Safe and convenient packaging for the parenteral delivery of oncology therapies

The development of new therapies for the treatment of cancer is a major focus for pharmaceutical companies as the global prevalence of the disease continues to rise. In 2018 targeted small molecule and biologic treatments made up around 91% of the late-stage oncology drug development pipeline, with alternative non-specific therapies such as cytotoxic agents, radiotherapies and hormones accounting for the remainder. Next Generation Biotherapeutics - cell, gene and nucleotide therapies – are particularly promising for oncology.

Over 50% (by volume) of cancer drugs are delivered parenterally, via injection or infusion. The vast majority of these drugs are classified as antineoplastics, drugs that work by preventing, inhibiting or halting the development of a neoplasm or tumor. Examples include: antimetabolites, plant base products, platinum therapies, monoclonal antibodies (mAbs), antibiotics derived from microorganisms, and alkylating agents. Most of these are small molecule drugs, mAbs being the important exception.

Glass vials or bottles and ampoules are used widely for oncology drug delivery. The majority of these drugs are supplied in liquid form, though lyophilization and reconstitution at the point of use is also routine. Drug stability and sterility throughout the supply chain are critical for patient safety, with particulates a notable concern, due to their ability to trigger immunogenicity and impact patient health*.

The wide variety of glass packaging available, along with the maturity of filling, sealing and labelling technology are important benefits and support the development of an optimised solution for every drug. Beyond these practicalities glass is prized for:

• Chemical stability, for a wide range of formulations
• Impermeability to gases such as O², which may compromise drug stability
• Heat resistance, suitability for hot filling and resorting
• Clarity, ease of inspection
• Mechanical resistance (notably molded glass) which is particularly important for the manufacture of cytotoxic drugs.

SGD Pharma offers a wide range of Type I & Type II parenteral products to meet the oncology market’s need for the most inert packaging and that answer directly to the demanding requirements of high value oncology products and novel cancel therapies. This range includes effective solutions for sensitive drugs, for high viscosity formulations and for those with high pH. The quality of SGD Pharma glass is extremely high and the company continues to innovate to meet evolving requirements. For example, the Sterinity platform has recently been introduced for the Ready-To-Use market.

* https://www.degruyter.com/view/...

An extensive portfolio of glass containers for the testing, analysis and diagnostics that drive the life science industries.

The lifesciences industry is driven by data, from rapid, point of care diagnostic testing for healthcare to increasingly sophisticated analyses that generate the information needed to develop new drugs. In vitro testing - literal translation ‘in glass’ – is routine, convenient, and cost-efficient relative to in vivo methods such as the clinical trials associated with pharmaceutical development. However, more generally glass containers of all types are a vital consumable across the life sciences for activities such as:

• sampling and sample storage
• cell culturing
• liquid handling and dispensing
• reagent, media and standards preparation and storage
• stability assessment.

Glass containers are chosen for these applications because they are:

• chemically inert and impermeable to gases
• easy to clean and sterilize, allowing re-use for many applications
• commercially available in a wide range of sizes and designs
• heat resistant

SGD Pharma’s broad portfolio of glass containers extends to molded products in Type I, Type II and Type III glass, in both clear and amber glass. A choice of neck finishes, for many products, makes it straightforward to match containers to specific applications; customized and plasticized products are readily available.