Injectables in Pharma

Medications delivered by injection bypass the body’s natural defence systems. This allows the medication to enter the bloodstream faster, resulting in more rapid therapeutic effects.

Injectable pharmaceutical products are highly regulated and must adhere to strict quality, purity and sterility standards. This is because they are injected into the patient and are therefore more susceptible to contamination from microorganisms and particulates.

Product Development

Injectables in pharma are pharmaceutical products that deliver drugs into the bloodstream or to a specific target site. They may include a drug dissolved in a solution, suspension, or emulsion and may also comprise complex delivery systems such as polymeric microspheres, lipid nanoparticles, reconstituted injectables, or pellet implants (e.g., perinatal injectables).

The development of sterile injectables presents many challenges due to aseptic practices and the need for detailed documentation. Recently, however, investment in robotics technology has cut down on mistakes and increased production speed. The final product undergoes a chain of tests to ensure quality. This includes sterility testing, endotoxin testing, and tests for extractables, leachables, and absorbables. It must also pass FDA tests for the injection device, including evaluation of needle penetration, accuracy of dose, and proper dispersion at the injection site.

Chronic illnesses and an ageing population have increased demand for injectable drugs. In fact, seven of the top 10 pharmaceuticals by sales in 2014 were injectables—a dramatic shift from a decade earlier when only one injectable made it into the top 10. This trend will likely continue for some time. Injectables also offer the potential to improve patient outcomes by enabling the fast and targeted delivery of therapies. Injections are a valuable tool in the treatment of cancer, infectious diseases, and immune and endocrine conditions.

Pre-formulation Studies

Preformulation studies are the foundation of a successful clinical drug development program. The choice and design of a formulation type can have a significant impact on the outcome of a preclinical study. The choice and quality of a preclinical formulation is critical for the success of a new medical product in preclinical animal testing, pre-clinical laboratory safety tests, initial volunteer/patient studies and full-scale clinical trials. A poorly designed or executed preclinical formulation can render results that are inconclusive and lead to unnecessary cost, delay and frustration.

Physicochemical properties of a drug compound are essential in preformulation studies, as they provide vital information to guide the formulation of an elegant, stable and biopharmaceutically-suitable dosage form. They include solubility, stability (solid and solution), permeability, partition coefficient, pKa/log P, polymorphic forms, salt screening, ionisation properties, and API-excipient compatibilities.

Preformulation studies help to identify potential issues that may arise during the formulation process, such as chemical incompatibilities, which are detected visually through color changes or physical form changes and quantified by spectrophotometric and calorimetry methods. In addition, sterility and stability of the final formulation are monitored during this phase using media runs. Preformulation studies are typically performed using binary or ternary systems consisting of a drug, diluent, and excipients used in lower proportions such as disintegrants and lubricants. This ensures that all ingredients have the ability to be mixed with each other without causing degradation of the pharmaceutical.

Sterility Assurance

Sterile injectables play a critical role in the global healthcare system, treating life-threatening diseases and managing chronic conditions. These drugs are administered directly into the bloodstream or tissues, bypassing the body’s natural defences, so maintaining absolute sterility is non-negotiable. The production of sterile injectables requires strict protocols and rigorous testing to ensure that they are free from contamination. The growth of the biologics pipeline, particularly in monoclonal antibodies and cell and gene therapies, continues to drive demand for sterile manufacturing capacity, with major pharmaceutical companies investing heavily in expanding their capacity.

Maintaining a controlled and clean environment is essential to avoid contamination during the production of sterile injectables, including using specialised machinery for aseptic manufacturing and sterile filling in facilities with state-of-the-art cleaning and sterilization technology. Strict gowning and hygiene protocols for personnel working in sterile areas are also required. Sterility assurance includes continuous monitoring of air quality, surface cleanliness, and microbial levels to identify potential contamination risks and implement corrective actions.

Sterile injectables must be tested at each stage to ensure that they meet the sterility assurance level (SAL) required for use in patients. This is determined by the number of samples taken from a batch, with the aim of detecting traces of contamination in the final product. In order to achieve a high SAL, processes such as radiation and autoclaving must be timed carefully to minimise the risk of contamination.

Packaging

Packaging is often one of the largest purchases a pharmaceutical company makes, and it is an important component in their success. From initial research and development to shipping the final product to the market, effective and compliant packaging must be at the heart of every stage.

Packaging for parenteral medications is particularly challenging. These life-saving drugs are packaged in sterile primary packagings (ampoules, vials, syringes or injectors) and then combined with their application components for delivery to patients. This requires a high degree of flexibility to accommodate small batch sizes and quick setup when changing batches, as well as ensuring the compatibility between packaging and components, such as needles.

Many pharma companies use aseptic fill-finish manufacturing to produce injectables, and these processes require advanced technology, testing and documentation to ensure full sterility. It is a very complex process that cannot tolerate any terminal sterilization, and it is therefore vital that all raw materials, processing steps, equipment and packaging remain completely sterile.

Pharmaceutical packaging also serves as a marketing and branding platform. Eye-catching designs and informative labeling can build brand identity, increase sales and encourage patient adherence by clearly outlining usage instructions and benefits. This can be especially important in self-medication, where adherence is key to avoiding adverse reactions and minimizing dosages. Additionally, pharmaceutical packaging should be child-resistant to prevent accidental ingestion of prescription medications.