Reliable, flexible and convenient packaging for the parenteral delivery of cardiovascular drugs

Globally, an estimated 17.9 million lives are lost to cardiovascular diseases each year, making it the highest cause of death. Acute events such as heart attacks and strokes account for around 80% of this mortality*. However, cardiovascular therapies also target a range of chronic diseases including coronary (or ischaemic) heart disease, cerebrovascular disease (conditions that affect the blood supply to the brain) and rheumatic heart disease (a long term impact of rheumatic fever). 'Orally delivered drug therapies are a vital strategy for the management of long-term cardiovascular health and include aspirin, drugs for controlling blood pressure (beta blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), Angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs), and diuretics) and drugs that control metabolic state (statins and anti-diabetes drugs).

Acute events demand more immediate treatments and are typically addressed via parenteral delivery, by injection or infusion, enables the rapid release of drugs, directly into the bloodstream. Drug concentration can be closely controlled and any damage to the drug from metabolism in the gastrointestinal tract is avoided. This can be particularly important for biopharmaceuticals, which are increasingly being used to target cardiovascular diseases. In hospitals, emergency drugs (epinephrine, norepinephrine), anti-coagulants, antihypertensive agents and drugs to tackle arrhythmia are all routinely delivered by injection or infusion to ensure a fast response to life-threatening cardiovascular conditions. As a result, parenteral delivery accounts for around 16% by volume of this vital drug sector**.

Glass packaging is adopted for a wide range of parenteral cardiovascular therapies. The most chemically inert packaging material for most formulations, glass helps to safeguard the stability and quality of drugs, up to the point of delivery. This can be essential for achieving a commercially acceptable shelf life, particularly for biopharmaceutical formulations. Other important advantages of glass packaging include:

• Impermeability, particularly to O2 which can compromise drug stability
• Clarity, for ease of inspection
• Mechanical resistance, which can be especially valuable for certain manufacturing processes
• Mature technology, for filling, sealing and labelling.

SGD Pharma’s portfolio for parenteral drug delivery includes a wide range of Type I & Type II injectable vials and infusion bottles. Glass quality is exceptional and the product range continues to evolve, for example, with the introduction of solutions for Ready-to-Use/Ready-to-Fill.

* World Health Organization fact sheet: Cardiovascular diseases (CVDs). May 2017. Available to view at: https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases

** IQVIA MIDAS Actual 2018

Flexible, high integrity packaging solutions for exemplary product quality and shelf life

Food, or dietary, supplements are an increasingly important part of everyday life. They include vitamin, mineral, herb or other plant-based chemicals, enzymes and amino acids, and are used from youth through to old age, to maintain or augment health. The term nutraceutical is variously applied to a subset of food supplements, typically to highlight a product with proven health benefits beyond those associated with basic nutritional values. The growing use of food supplements is part of a trend towards self-medication, with around 77% of patients recently stating a wish to be involved in their health*. The increasing use of cannabidiol (CBD), a derivative from cannabis, is a major innovation within this industry with the number of CBD-based products soaring.

Food supplements and nutraceuticals are typically self-administered and consumed orally. Common product forms include droppers for tinctures, syrup bottles for functional beverages, tablet bottles for weight management. Degradation caused by exposure to UV radiation, an issue for some products, can be prevented through appropriate packaging selection. 'Since these products are not prescribed but rather directly purchased by consumers, ease of use and shelf appeal are key.

Glass packaging offers a number of key benefits for food supplements, including:

• A high level of chemical stability
• Excellent resistance to variability in temperature and humidity
• Optimum protection against degradation by UV light and O², which is particularly important for vitamins.

SGD Pharma’s extensive portfolio for food supplements helps manufacturers to maintain product integrity and extend shelf life. It includes an array of molded, amber, Type III glass solutions, notably dropper bottles, from 5 to 100 ml in volume, as routinely used for tinctures, the preferred form for over 53% of CBD Products**. Bottles for syrups and oral solid dosage forms with a choice of neck finish types are also available.

* Ipsos poll/2018.

** SGD Pharma internal estimation as of April 2020.

Easy to use, high resistance packaging solutions for the parenteral delivery of drugs that target the brain and central nervous system (CNS).

Therapies for the treatment of neurological and mental disorders are an important fraction of the pharmaceutical market. Such disorders include epilepsy, schizophrenia, stroke and brain trauma, depression, vascular dementia, Alzheimer’s and Parkinson’s disease, and their prevalence is significant. For example, epilepsy which is one of the most common neurological disorders affects around 50 million people globally*. Psychoanaleptics and psycholeptic, drugs that arouse or calm respectively, account for a substantial number of therapies for these disorders and growth in the use of biotherapeutics is an important trend. Cannabidiol (CBD)-based products have also proven effective, particularly for the treatment of epilepsy. Drugs with either neuro-protective and/or neuro-regenerative properties are vital for the treatment of both degenerative diseases and acute conditions such as trauma or stroke.

The brain and CNS are extremely well-protected and penetration of the barriers that maintain their microenvironment is a major challenge when it come to delivering drugs for neurological conditions and mental disorders. Raising systemic concentrations of the drug to relatively high levels is a common strategy**. Parenteral drug delivery enables the precise control of drug levels in the body and can be used for extended drug release products, or conversely, to achieve rapid drug delivery and action. It is particularly valuable for patients or conditions ill-suited to oral therapies. Around 20% by volume of drugs delivered parenterally are for the treatment of conditions associated with the brain and CNS***.

Glass packaging is routinely selected for high value drugs formulated for parenteral delivery because it is:

• the most chemically resistance material for many formulations
• highly impermeable, which can be critical for drug stability
• heat resistant, enhancing suitability for lyophilization and other forms of heat treatment
• when it comes, facilitating product inspection.

SGD Pharma offers a wide range of Type I & Type II glass packaging for drugs for neurological and mental disorders, notably injection vials and infusion bottles in a range of volumes. The portfolio includes high integrity solutions to maintain the shelf-life of biopharmaceutical drugs which can be extremely sensitive to extractables and leachables. Solutions for high viscosity formulations and for those with high pH are also available.

Follow the links to find out more about the products available:

* Who Health Organization fact sheets: Epilepsy. June 2019. Available to view at:

https://www.who.int/en/news-room/fact-sheets/detail/epilepsy

** C.T. Lu ‘Current approaches to enhance CNS delivery of drugs across the brain barriers’ Int J Nanomedicine. 2014, 9 pp2241 – 2257. Available to view at:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4026551/

*** IQVIA MIDAS Actual 2018

Superior, product-specific packaging solutions for the intravenous delivery of pain relief.

An essential element of routine healthcare, analgesics relieve pain by blocking signals from the nerves or distorting the interpretation of such signals by the central nervous system. Most fall into one of three classifications: narcotics or opioid pain relievers; non steroidal anti-inflammatory drugs (NSAIDs), or paracetamol (acetaminophen). Drugs in the two latter classification are widely used as the first line of defence for mild pain relief. Though typically supplied in oral solid dosage form, analgesic drug delivery via alternative routes is routinely essential, for example, post-operatively or for pain management in patients with compromised digestion. Beyond tablets paracetamol is available as a powder, solution, suspension or suppository and is often delivered by injection or infusion. Overall, around 20% of the analgesics market, by volume, is delivered by these latter two routes.

Glass packaging is particularly suitable for analgesics for injection or infusion, offering:

• High impermeability, notably to oxygen
• Clarity, for ease of product inspection
• Widespread acceptability and familiarity.

SGD Pharma is a leading supplier of 100 ml infusion bottles for pain relief therapies, specifically paracetamol, offering products uniquely specified to meet the demanding requirements of this application. High impermeability is critical in preserving the quality of the drug, which can deteriorate in the presence of trace levels of oxygen. More generally the portfolio includes a wide range of solutions for parenteral delivery (both by injection or infusion), in Type I and II glass. Dropper bottles in Type III glass, in the range 5 – 100 ml, are a cost-effective choice for oral analgesic delivery.

Highly stable, cost-effective, eco-friendly packaging for Standard Solution and Parenteral Nutrition drugs manufacturing.

Standard Solutions and Parenteral Nutrition (PN) are vital elements of effective healthcare for many patients. Delivered intravenously, they form part of a set of medical nutrition strategies that includes oral nutritional supplements and enteral feeding and are typically adopted when enteral strategies are either insufficient or unsuitable (due to, for example, coma or dysphagia). PN becomes essential when digestive function is severely compromised and its use is growing significantly, in line with increasing levels of cancer and the rising prevalence of malnutrition.

Standard Solutions, of sterilized water and salt or Water for Injection and glucose, are delivered for rehydration and to meet basic energy requirements, respectively. Parenteral admixtures, the large volume sterile infusions delivered to patients requiring PN, are substantially more complex and specified to completely fulfil nutritional requirements. They may incorporate a wide range of amino acids; carbohydrates e.g glucose, and lipids; electrolytes; trace elements and vitamins. Admixtures are industrially manufactured or prepared locally within the hospital under aseptic conditions. In hospital preparation is typically for direct administration; industrial products may require a substantially longer shelf life.*

Packaging associated with drug manufacturing of Standard Solutions and PN ranges from ampoules for individual substrate components, to large volume containers for ready-to-use aqueous solutions, through to options for all-in-one formulations that also incorporate lipids. The sterility, purity and stability of solutions and admixtures is a critical issue, since these parameters directly impact patient health. As with any infusion, particulate contamination is a major concern since the introduction of particulates can trigger severe health effects.

Glass packaging offers many important benefits for Standard Solutions and PN applications. These include:

• A high level of chemical stability to a wide range of components and solutions, including high concentration calcium and magnesium salt electrolyte solutions
• Excellent resistance to variability in temperature and humidity
• Ease of inspection during entire drug life cycle (from production to administration by a nurse).

SGD Pharma delivers a wide range of products for Standard Solutions and PN, primarily manufactured in Type II or Type I glass.

* M Barnett et al. ‘Basics in clinical nutrition: Parenteral nutrition admixtures, how to prepare parenteral nutrition (PN) admixtures’ e-SPEN, the European Journal of Clinical Nutrition and Metabolism (4) 2009

Cost-efficient, eco-friendly packaging solutions to preserve the integrity of herbal and homeopathic medicines.

Phytotherapy combines the heritage of traditional herbalism with modern pharmaceutical practice to provide clinically effective plant-based treatments for a range of common ailments and illnesses. Though similar in terms of advocating a holistic, ‘natural’ approach, homeopathic remedies are not exclusively plant-based, but may also use animal or mineral substances. The use of both types of medicine is growing strongly as consumers in developed economies embrace naturally derived remedies in place of “conventional” pharmaceuticals. Products for the treatment of respiratory tract diseases, gynaecological and urological issues, pain and ailments of the gastrointestinal tract and digestive system are particularly prevalent; around 30% of the phytotherapy market is associated with cough and cold remedies*.

Phytotherapy and homeopathy products are almost exclusively formulated for oral delivery, as droppers, syrups or tablets, and predominantly sold over-the-counter and through other distribution channels. Overall, phytotherapy and homeopathic products form a significant fraction of the healthcare market. Bottles, and more specifically in amber glass, are essential for these products, many of which are UV sensitive. The use of appropriately protective packaging is therefore vital.

Glass packaging offers a number of valuable benefits for phytotherapy and homeopathic products such as:

• Flexibility, with a wide range of different packaging solutions to choose from
• Optimum protection against UV light radiation
• Well-established filling and sealing technology
• Ease of re-use and disposal.

SGD Pharma’s extensive portfolio for this market includes a wide range of molded solutions in both clear and amber glass; Type III glass is a popular choice for many products. Syrup in volume from 30 to 1000ml and tablet bottles range; dropper bottle sizes run from 5 to 100 ml. A choice of neck finishes makes it straightforward to match packaging to specific filling and sealing requirements.

* SGD Pharma internal estimation as of April 2020

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.