One aspect of medicine that is often taken for granted is the way a drug is actually delivered to the body. Drug Delivery is the method or process of administering a pharmaceutical or biotech active pharmaceutical ingredient (API) to achieve a therapeutic effect in humans. Drug Delivery technologies may be used to modify a drug release profile, absorption, distribution and elimination for the benefit of improving product efficacy, safety, patient convenience & compliance, and even reducing cost to the patient.
Companies may apply drug delivery technologies to maintain market share for drugs about to go off patent. It can be used to differentiate drugs in a competitive market, such as in generics and follow-on biologics. Lately, companies have been using it as an enabling technology. Many drugs would not make it to market without sophisticated drug delivery technology.
Drug Delivery is achieved by a broad range of approaches in including enhancing formulations, using medical devices, and even altering the structure of the API. Historically, the great majority of drugs have been delivered orally via tablets, capsules, liquids, etc. However, pharmaceutical companies, which have traditionally depended upon small-molecule API’s for their supply of novel therapeutic treatments, are increasing looking to biotechnology for new drugs.
Currently, almost all biotech drugs are delivered parenterally, most by intravenous injection (IV) and subcutaneous injection (SQ). Because delivering a drug by injection bypasses the selective barriers of the GI system, much care must be taken to ensure highest quality for medicines that are injected. Regulatory requirements for the analysis of purity are much higher for injectables than for other routes of administration.
In particular, protein therapeutics require extra care in order to ensure safe, stable and efficacious delivery. Proteins are susceptible to a wide variety of degradation mechanisms. In addition, the delivery technology (or impurities contained therein) may interact with a protein rendering it adulterated. The stringent purity requirements to detect traces levels of impurities require great skill in the analytical sciences.
These and many other challenges are why companies are increasingly utilizing drug delivery technologies to improve biologic stability, solubility, serum half-life, efficacy, toxicity, immunogenicity, and targeted delivery.
At Analytical Ventura, we have years of experience characterizing drug delivery systems, and we have described many of them in the linked pages. Our scientists are happy to work with you to help you with your application and will work best for you and to develop a solution most suitable for your analytical challenges.