What are injectable products?

Injectable Products

Medications administered through injection bypass the digestive system, ensuring that drug particles reach the body in their sterile form. Injectable drugs can also be delivered in convenient pre-filled syringes that offer patients easy, safe self-administration, helping to improve compliance.

As disease conditions increase in prevalence and patients shift care from clinic to home, meeting the needs of this evolving market will require drug owners to develop new injectable products that provide both clinical efficacy and differentiated administration experiences. This will require strategic production partners who can deliver multifaceted technical expertise and solution customization.

What are injectable products?

Sterile injectables are drugs or medications that are administered through a needle and injected into the body, either intravenously (IV) or subcutaneously (SC). Unlike solid medicines, which must be swallowed orally to become effective, sterile injectables deliver their therapeutic benefits directly into blood vessels and tissue.

This fast-growing segment of the pharmaceutical market is being driven by four major concurrent trends. These include an aging population with chronic illnesses that require long-term treatment, government initiatives for the development of new biologics, and shorter R&D and approval times for sterile injectables than other drug types.

In addition, patients are demanding a user-friendly injection experience that supports their adherence. To meet this demand, biopharma must now design products that combine an efficacious molecule with a complete delivery and handling system optimized for convenience and patient-friendliness.

Injectable pharmaceutical formulations are manufactured in a variety of forms including suspensions and emulsions, prefilled syringes, pens, and autoinjectors. Many of these devices are connected to software systems that can record and report medication use data for regulatory compliance purposes. To produce these innovative and highly complex drugs, pharma companies must have a reliable supplier that offers specialized equipment to maximize output with sterility protection. This is where a pharmaceutical injectables filling machine manufacturer can make all the difference. By implementing an automated and efficient production line with a high-quality liquid injection machine, drug makers can ensure the safety and quality of their sterile injectable products.

How are injectable products made?

The pharmaceutical industry uses various injectable filling lines or machines to manufacture different types of sterile injectable products, such as general injectables and cytotoxic injections. These machines are capable of producing high-quality sterile injectable drugs in accordance with strict sterile manufacturing regulations.

Generally, an injectable drug is administered through a needle inserted into the skin, muscle, bone, or veins. The pharmaceutical company must ensure that the product is sterile from end-to-end by performing several tests on each individual component. This includes testing for dose accuracy, demonstration of depth of needle penetration, and ensuring that the product is dispersed into the target area. The company must also perform special tests on the prefilled syringe to evaluate extractables, leachables, and absorbables, along with tests for container-closure integrity and shelf-life dating.

Liquid injectables are made up of a mixture of non-drug (excipient) and active drug components suspended or dissolved in a single solvent. These formulations offer the advantage of faster therapeutic effects compared to solid drug dosage forms, such as tablets and capsules, which are slow to reach the target site.

Injectables are also ideal for drugs that cannot be absorbed through the gastrointestinal tract or destroyed by digestive secretions. Examples include antiviral peptides, such as the antiviral medication Fuzeon(r) developed by Roche. These oligopeptides target multiple viruses and can be administered by injection, subcutaneously.

What are the benefits of injectable products?

Injectable products have become an increasingly popular delivery system for drugs. They are characterized by their versatility and ability to provide precise, patient-friendly doses. They also offer advantages over oral medications, such as ease of administration, patient convenience, and reduced dosage errors and waste.

In addition, sterile injectables are particularly well suited for long-term therapy because they allow patients to self-administer medication on a daily basis. This can help to reduce costs and improve compliance with treatment regimens. The market for sterile injectables is growing rapidly because of a number of factors, including increased prevalence of chronic diseases, rising research and development costs, and increasing demand for at-home treatments.

Lipidic formulations like liposomes, solid lipid nanoparticles, and lipid emulsions have gained popularity for drug delivery due to their unique properties such as enhanced solubility and permeability. These formulations are typically made using phospholipids like egg phosphatidylcholine, hydrogenated soybean phosphatidylcholine (HSPC), and glycerophosphate choline that act as functional excipients.

These complex formulations are undergoing extensive research for their development, manufacturing, and characterization. However, they face challenges because of their complicated structure and the lack of detailed guidelines from regulatory agencies regarding their characterization and bioequivalence studies. In order to alleviate these issues, the development of a reliable method for characterization of these complex products is required. This would allow generic manufacturers to develop more robust characterization studies for their formulations and accelerate the approval process.

What are the challenges of injectable products?

As chronic conditions such as diabetes, heart disease and COPD continue to grow in prevalence and economic impact, patients are demanding more patient-centric ways to self-administer their therapy. This shift is prompting innovation in injectable drugs with devices that facilitate more independent and flexible care at home. It is also driving greater emphasis on designing drug-device combinations that enable more convenient, safer and user-friendly injections.

Prefilled syringes are one example of this trend, providing a ready-to-inject solution that eliminates the need for product reconstitution and helps reduce the risk of needlestick injuries. These innovations can improve compliance by making it easy and safe to administer medication, especially for those who may have visual impairment or limited manual dexterity.

Complex injectables are a significant challenge for pharmaceutical companies, as they often require specialized formulation, characterization and testing. They also present a number of hurdles in terms of regulatory filing and approval pathways. This is because of the unique quality attributes, non-conventional testing requirements and the complexities in their design (e.g., multiple injection points and volumes) [123].

Moreover, these products are often made using nano-scale components. The use of these materials requires advanced processing techniques such as high-pressure homogenization (HPH). HPH is a robust and scalable method to prepare complex parenteral drugs, including nanoparticles, liposomes, microspheres, suspensions and emulsions. These formulations are often thermolabile, which further complicates the sterilization decision process.

Find out more info: supal pharmacare ltd