Pharmaceutical formulation is the process in which different chemical substances are combined to produce a final medicinal product, or drug. The final product may be in the form of oral medications, topical formulations, or injections. Oral pharmaceuticals normally come in the form of a tablet, capsule, or liquid. Topical formulations can take the form of creams, gels, powders, liquids, ointments, and pastes. IriSys performs dosage form development in order to provide a wide variety of world-class pharmaceuticals for Phase I and Phase II clinical trials. Some of the medicinal products we manufacture include tablets and capsules, injectables, and gel, cream, and liquid dosage forms.
Pharmaceutical formulation is becoming increasingly popular as the market for medication continues to grow rapidly. Every year, the pharmaceutical industry is inundated with the testing of tens of thousands of new substances. Due to rigorous production and manufacturing standards and costs of testing, several medications are never fully developed. Still, today, thousands of medications are available for a variety of uses, some of which include diagnosis, prevention, treatment, and therapy. For example, several pharmaceuticals exist to aid in the treatment of infectious diseases. In addition, there are certain medications offered to help prevent and treat cardiovascular diseases. There are also drugs to treat pain, respiratory system diseases, consciousness, skin diseases, allergic disorders, and much, much more.
Pharmaceutical Production and Distribution
The actual production and distribution of pharmaceuticals is typically the last stage in an extremely lengthy process. The process usually begins with in-depth scientific research. Often times, this stage is initiated by the Research and Development (R&D) departments of pharmaceutical and medicine manufacturing companies. Once a chemical compound is created, the mix must be tested, or “screened.” The testing process varies for each pharmaceutical formulation. For example, in order to screen an antibiotic a sample of the product is placed in a bacterial culture. Then, if the antibiotic is effective, it is tested on infected laboratory animals. If successful, the compound goes through more testing and development before a final product can be manufactured.
Testing pharmaceuticals is a very tedious, lengthy, costly process that results in a minute amount of compounds eventually becoming approved medications. After screening the compounds, pharmaceutical manufacturing companies and development perform clinical investigations, more commonly known as clinical trials. Individual clinical trials vary greatly, but the basics are as follows. The clinical investigations are conducted on human patients. The investigations consist of various stages, typically no more than three stages. During clinical trials, doctors and scientists administer drugs which have passed initial testing to various groups of people while observing each person, determining and adjusting dosage levels, and monitoring side affects. If the pharmaceutical appears useful and functional, additional tests are conducted until all phases of the clinical trial are completed. If a drug successfully passes the human clinical trials, the FDA’s Center for Drug Evaluation and Research (CDER) thoroughly reviews the drug’s performance before approving it for commercial use and distribution. The entire pharmaceutical formulation process can take several years, even decades, and can cost hundreds of millions of dollars.
IriSys tailors the formulation to the drug’s physical
and chemical characteristics, each formulation is unique to the
compound. The Company provides world-class dosage form development services, both classical and proprietary. IriSys’ team
understands the long term benefits and advantages of various dosage
form technologies for small molecules, peptides and proteins. The
staff of prominent leaders from academia and industry combine expertise
in every facet of dosage form development including requirements
of the Chemistry, Manufacturing and Controls (CMC) section of the
Investigational New Drug application (IND). IriSys offers
the capability of bringing new products to the market quickly and
efficiently. Novel formulations are a consideration when
requested for patent extension purposes.
IriSys develops formulations
for new chemical entities, OTC products, generic products, and
505(b)(2) product candidates. The company
develops the following dosage forms.
- Capsules, powder-filled
- Capsules, liquid-filled
- Oral solutions and suspensions
- Topical products
- Controlled release products
- Sustained release products
- Lyophilized products
- Animal study materials