May is Asthma Awareness Month with May 5th having recently been celebrated as World Asthma Day, a day dedicated to raising awareness about a common chronic disease. It has been estimated that 1 in 13 Americans lives with asthma, associated with wheezing, coughing, breathlessness and a tightening of the chest. As per the 2018 Global Asthma report, there are a thousand people who die of asthma every day.
According to the Unmet Global Burden of COPD 2018 Report, Chronic Obstructive Pulmonary Disease (COPD) affects over 338 million people worldwide, and is one of the leading causes of death.
Navitas Life Sciences and Inhalation study Capabilities
There are many respiratory diseases that are treated using inhalation as the route of administration, as a larger concentration of the drug can reach the lung or the target organ. This has also been shown to reduce the systemic effect of these drugs.
Benefits of inhaled route of drug administration
- Preferred by patients to injections
- Rapid absorption of drug to target site
- Requires smaller doses
- Better efficacy to safety ratio when compared with systemic
- High and long-term pulmonary efficacy
There are multiple inhalation devices that are used to deliver a fixed amount of such drugs in the market - including nebulizers, pressurized metered-dose inhalers (MDIs), and dry-powder inhalers. There is a need for stringent testing of such drugs in clinical trials, with the need for adequate resources and capabilities to test both their safety and efficacy.
4 Ways Navitas Life Sciences Supports Inhalation Studies
Inhalation studies are one of the most nuanced and challenging areas of study, requiring specialized expertise and facilities. Here are 4 ways Navitas Life Sciences are supporting inhalation studies.
1) Specialized Inhalation chamber for inhalation studies: Inhalation studies require special facilities that help in delivering the required dosage via the nasal route. Such facilities ensure that the studies are conducted with the highest level of regulatory compliance.
The delivery of the drug product using the inhalation method requires a combination of specific facilities as well as exposure systems and analytical techniques. We have the capabilities for supporting such studies to provide safety and efficacy data to meet stringent regulatory guidelines.
Highlights of Inhalation Study Facility with Navitas Life Sciences
- Dosing in a segregated area
- Negative air chambers to prevent cross contamination
- Canisters weighed before and after dosing
2) World Class Lab Facilities specific for Inhalation studies: There are dedicated wet lab and instrumentation rooms. Samples are analyzed in our State of the Art bioanalytical facilities with AB-Sciex 6500 LC-MS/MS that can measure even the lowest Lower Limit of Quantification LLOQ.
Our Clinical laboratories performing pathology testing are accredited by NABL (National Accreditation Board for Laboratories; ISO15189-2012) and CAP (College of American Pathologists). Our facilities, systems and processes have been inspected successfully by the USFDA, WHO, EMA (ANSM/AGES), Thai FDA, NPRA & DCGI
3) Proficient Bioanalysis Methods: Our experts have developed bioanalytical methods to measure Mometasone, Fluticasone, Formoterol, Albuterol, Tiotropium and Ipratropium. Apart from these, new methods can be developed and validated in 4 weeks.
Pseudoephedrine (Tablet), Guaifenesin & Dextromethorphan (Tablet) Guaifenesin & Dextromethorphan (Expectorant, Plasma), Albuterol (Spray), Albuterol Bronchodilator(Plasma), Chlorpheniramine & Pseudoephedrine, (Ibuprofen) (Tablet), Montelukast (Granule), Tiotropium (Spray), Ambrisentan (Antihypertensive (Pulmonary, Plasma) | Budesonide (Asthma & COPD Treatment, Plasma), Chlorpheniramine & Pseudoephedrine
(Ibuprofen) (Antihistaminic & Decongestant Plasma), Formoterol (Asthma & COPD Treatment, Plasma) | Montelukast (Asthma treatment, Plasma), Theophylline (Bronchodilator (Bronchial smooth muscle relaxant, Plasma)
Bioanalysis Methods available for the following
- Mometasone (1pg/mL)
- Fluticasone (1pg/mL)
- Formoterol (0.4pg/mL)
- Albuterol (20pg/mL)
- Tiotropium (0.5pg/mL)
- Ipratropium (0.5pg/mL)
4) Experts in the field of inhalation studies: Our inhalation experts are highly experienced and have deep domain expertise. They have the necessary skills to characterize the various aspects of inhalation drug delivery and to closely monitor progress of the patient.
During the current COVID-19 pandemic, inhalation studies for respiratory conditions are important, and could craft the way to better treatment measures. Navitas Life Sciences has the required expertise and infrastructure to help bring lifesaving inhalation products to the market sooner and efficiently.