New syringe design results in improved drug stability and gentler injections
Pharmaceutical stability studies are finding that some of the new drugs currently on the market present greater challenges when it comes to maintaining stability. “There is a growing segment of biotech drugs that are not only highly effective but also very sensitive,” explains Ralf Bouffleur, Vice President of SCHOTT Pharmaceutical Packaging. “The reliable protection of these drugs during storage is now calling for innovative packaging solutions.”
To meet this need, this German company developed SCHOTT InJentle™, an innovative syringe that both prevents the drug from coming in contact with the needle or the adhesive during storage, and is more comfortable for patients. Pulling off the needle shield activates flow from the barrel, reducing the amount of time that the drug is in contact with the needle and allowing healthcare workers to accurately determine if the syringe has already been used.
In addition, the shape of the syringe has been engineered to eliminate the need for using tungsten in the glass-making process. The up to 32 gauge needle is very thin, and according to the Product Manager Carmen Heiter, “The thinner the needle, the less painful the injection.” She goes on to say, “The syringe is delivered with standard nests and tubs and can be filled on standard filling lines.” Its ease of use means that no special training of personnel is required.
Best-in-Class Stability Studies Providers:
- Test for drug stability under long-term conditions (e.g. 25°C / 60% rh) continuously over the period of the labeled shelf-life
- Test all finished products and bulk products that have been stored or transported for prolonged periods
- Test every product in every dosage and pack size or primary packaging type
Top Considerations Before Selecting Stability Studies Provider:
Maximum efficiency can be achieved by making sure that a well organized inventory system is in place. This will ensure that enough sample material is available without incurring the cost overage of storing too much. When samples are removed from storage, this should be documented to make sure that stocks are maintained. Strictly adherence to best practice storage and handling protocol is essential.
Key Producers:
1. Rules-Based Medicine (RBM) reports that each analyte in RBM's Multi-Analyte Profiles (MAPs) has its own set of calibrators and stability controls. In order to achieve the sensitivity and dynamic range necessary to quantify the target analyte, each assay is first developed as a single-plex test and then the resulting single-plex assays are aggregated. Validation of these multiplexed assays with a battery of analytical procedures using assay parameters of least detectable dose, lower limit of quantification, precision, cross-reactivity, linearity, spike-recovery, dynamic range, matrix interference, freeze-thaw stability and short-term sample stability completes the development process. This CLIA-certified biomarker testing laboratory has its corporate headquarters and biomarker testing laboratory in Austin, TX; and multiplex assay development in Lake Placid, NY.
2. Covance Inc. offers cGMP-compliant stability and release services for both large and small molecule drug active pharmaceutical ingredients (API) and drug products. Covance’s services run the gamut from analytical or biological method development through regulatory submission and commercial QC testing. Stability testing facilities are fully validated and inspected. The company reports “With our focus on quality and process excellence, you are covered by Covance's standing operating procedures (SOPs) if an out of specification event takes place.” Covance has headquarters in Princeton, New Jersey, and more than 10,000 employees in Europe, the Asia Pacific Rim, and Central and South America. In the late 1980s and early 1990s, Corning, Incorporated acquired several drug development companies, some with roots dating back to the 1940s. Covance Inc. was spun off from this division in 1997.
3. Diteba Research Laboratories Inc. has a dedicated Stability and Analysis group that provides services for all stages of drug development, from early research and development to commercial/post approval studies. These services are provided in full compliance with ICH, Health Canada and FDA guidelines. Its stability department is integrated within the laboratory complex and provides the following services: Protocol Design; Long Term Stability; Accelerated Stability; Drug Substance Stability; IND, NDA, ANDA Stability; Commercial Product Stability; Comparator Stability; Formulation Evaluation Stability testing; Forced Degradation studies; and Photostability and Temperature cycling. Its mission statement states “As a pharmaceutical contract research organization, we strive to be an innovative and cost-effective partner that delivers consistent and quality service with unmatched integrity.” Diteba was founded in 2003 and is based in Mississauga, Canada.
4. The Jackson Laboratory’s scientists support pharmaceutical stability studies by developing technological breakthroughs for use in the research community at large, in addition to their research into developing disease model systems. The Jackson Laboratory’s services include testing numerous medicinal entities, including small molecules, antibodies, siRNAs and ES cell-derived therapies, as well as customizable compound evaluation, phenotyping and pathology services. In addition to conducting genetic research into ways to prevent cancer and to discover drugs to treat conditions including: cancer, diabetes, Alzheimer’s and cardiovascular disease, this independent, nonprofit organization provides scientific resources, techniques, software, data and mice colonies for test animals to scientists in research institutions and laboratories around the world. The Jackson Laboratory is an NCI-designated Cancer Center with facilities in Maine and California.
Stability Studies
Definition: Pharmaceutical stability studies or drug stability studies determine the shelf life, which is the storage time period under specified conditions within which the drug product still meets its established specifications concerning its identity, strength, quality and purity. A drug that does not have sufficient stability can experience changes in physical (like hardness, dissolution rate, phase separation, etc.) as well as chemical characteristics (formation of high risk decomposition substances).
