World COPD Day 2021 was celebrated recently, and it brought with it the awareness to find better solutions for Chronic Obstructive Pulmonary Disease (COPD). Navitas Life Sciences supports treatment for people with COPD, resonating with the theme for World COPD Day “Healthy lungs- Never More Important”.

According to the World health Organization, COPD is the third leading cause of death globally. It causes progressive and persistent respiratory symptoms like cough, phlegm production and breathing difficulties and resulted in 3.23 million deaths in 2019.

Some of the important factors associated with development of COPD are exposure to harmful gases, including occupational exposure, smoking and indoor air pollutions, along genetics. A study by Jones et al has shown that there is a reduction in the quality of life among people with COPD, with other studies showing a decline in physical activity. Even in early stages of the disease, most patients were found to be walking and standing, while they spent more time sitting and sleeping, when compared with healthy individuals.

A study aimed at identifying the projected economic burden of COPD, between 2019 and 2038 in the United States, estimated direct medical costs associated with COPD to be nearly $800 billion, while estimated indirect absenteeism costs was found to be nearly $100 billion.

As a result of the higher impact on the quality of life and the economic impact, it is important to identify pharmacological interventions that will help people with COPD.

Inhalation Studies Clinical Trials

Inhalation offers a significant advantage over other methods of administration of medication as the drug is delivered directly to the lungs, which ensures a high concentration of the active ingredient at the site of action, and low systemic levels of the active ingredient. Thus, inhalation drug delivery devices ensure high drug efficacy with minimal side effects, making it the most popular choice for management of respiratory diseases.

The surface area of human lungs is large and consists of a highly permeable epithelium that makes it easier for inhaled medicines to be accessed. Inhaled drugs are used in the treatment of asthma, COPD, pneumonia, cystic fibrosis, and even for COVID-19.

Experience World Class Infrastructure and Expertise of Qualified Experts for your Inhalation Studies

Navitas Life Sciences’ dedicated team of experts have the vast experience and in-depth domain knowledge to support your clinical trial needs. Leverage our ability to identify and mitigate risks and challenges by developing the appropriate study design to demonstrate the bioequivalence of your product effectively and scientifically.

Accreditation for Our Clinical laboratories

NABL- (National Accreditation Board for Laboratories; ISO15189-2012)

CAP- (College of American Pathologists)

Our facilities, systems and processes have been inspected successfully by

USFDA, WHO, EMA (ANSM/AGES), Thai FDA, NPRA & DCGI

We met with Dr. Raghavendra Shetty, Assistant Vice President - Bioanalytical atNavitas Life Sciences to understand how we are supporting Inhalation studies and how our unique capabilities help bring lifesaving drugs for respiratory diseases to the market effectively.

Give us a snapshot of your professional background

I completed my Postgraduate in Pharmaceutical Quality Assurance from Manipal University, Manipal and Doctorate in Pharmaceutical Science from NIRMA University Ahmadabad. I have 17+ years of experience in the field of bioanalytical research. I started my career as Bioanalytical scientist at an Indian Pharma Major involved in Drug Discovery and research, before eventually moving to Clinical Research and joined Acunova (now Navitas Life Sciences) and became involved in setting up the bioanalytical laboratory, systems, and processes. My Core strength is in developing novel methods for bioanalysis, and I was involved and mentored developing more than 300 methods and have supported more than 1000 BABE studies to date at Navitas Life Sciences. I have also been a part of various regulatory inspections with both national and global agencies, including CDSCO, USFDA, EMA, WHO and NPRA.

Currently I am the Assistant Vice President of Bioanalytical, and I head the Bioanalytical laboratory for both Manipal and Bangalore. We have a team of 60 highly qualified experts who work in the bioanalytical division.

Dr. Raghavendra Shetty,

Assistant Vice President,
Bio-analytical,
Navitas Life Sciences

Please give us a glimpse of your role at Navitas Life Sciences, in terms of supporting inhalation studies?

At Navitas Life Sciences, I provide technical supervision to the bioanalytical operations and overall administrative oversight for ourBioanalytical Laboratories.

With regards to inhalation studies, considering the technical challenges, as a Study Director, I strategize the overall approach with specific emphasis on a method development approach, choice of instrumentation, and personnel to execute the projects in a scientifically planned manner to achieve the desired quantification limits.

We have a dedicated well-trained team of bioanalytical scientists who are specialized in developing sensitive and robust methods capable of providing quantitation at sub-picogram level, which is a critical attribute for the success for any inhalation study.

What are the challenges in executing the Pharmacokinetic studies for Inhalation products (MDI, DPI, Nasal Spray)

The clinical challenges of study conduct subjects’ training, infrastructure for contamination free dosing, and relevant expertise and experience of the team. The bioanalytical challenges include availability of high-end LCMS/MS, and capability to develop robust analytical methods with sub picogram level quantitation.

I am pleased that we have qualified/trained investigators to support inhalation studies. The study team is well versed in Spirometry testing and handling inhalation training instruments such as in check dial, Vitalograph-AIM, that help in preparing the volunteers right inhalation technique to ensure dosing compliance. This is very critical step in ensuring the success of inhalation study.

Communication plays a very important role in training the volunteers for inhalation studies. Our staff have been appropriately trained to ensure that we adopt an effective and result oriented approach in ensuring proper inhalation techniques with minimum process variability.

To overcome cross-contamination during dosing we have installed negative air chambers and dedicated infrastructure that is exclusive for inhalation studies.

On the Bioanalytical front, having a robust bioanalytical method with reproducibility at sub-picogram level is a cornerstone for the study success. During bioanalytical execution of the project, it is very challenging and critical to ensure contamination free environment and high level of diligence during sample processing. We have the skills to develop bioanalytical methods, within 4 weeks of project initiation. All this is possible owing to our exclusive and highly qualified team, many of whom have been working withus for more than a decade.

What are the specific requirements for delivering PK studies of Inhalation products?

• Infrastructure like Negative air chamber, Training devices (In check dial, Vitalograph, Spirometry), qualified/experienced Investigators
• High end LC-MS/MS for low level of quantification, dedicated instrument room and processing lab, well experienced & skilled scientist

What are the advantages in choosing Navitas Life Sciences for inhalation studies?

• We have handled 10+ inhalation studies with MDI and DPI
• We have the experience and capabilities to meet both customer and regulatory expectation
• We have the capabilities to fulfil the additional requirements during screening interpretation, review of Spirographs, and acceptability
• We can handle different training devices
• Experienced and qualified staff to ensure proper Volunteer training to ensure reproducibility volunteer training for the efficient dosing techniques/instructions.
• Well trained and experienced pharmacist to manage the IP handling (Priming and weight variation check)
• Dedicated facilities to manage the IP administration (dosing chambers with continues negative airflow), videography of IP administration
• Skilled and experienced phlebotomist/staff nurse team to manage the frequent post dose blood sampling and processing
• Bioanalytical capabilities to validate the methods in very low level of quantification with sophisticated high-end instruments

Navitas Life Sciences has highly qualified experts, and the necessary technical expertise as well as facilities like inhalation chambers and state of the art instrumentation.

Exclusively Designed Study Conduct

• Good Volunteer Access: Focused subject selection & training on Metered Dose Inhalation
• Adequate Handling: Dosing in segregated area & videography
• Proper Dosing Facility: Negative air chambers to prevent cross contamination
• Focus on Optimum Dosing: Canisters weighed before and after dosing
• Competitive Expertise: Extensive expertise across multiple inhalation studies

We have the expertise to support the entire study, from enrolling and training volunteers to report delivery.

Expert Bioanalysis

• Specially Developed Bioanalytical Methods: Readily available bioanalytical methods for Mometasone, luticasone, Formoterol, Albuterol, Tiotropium and Ipratropium
• State of the Art instrumentation: Allows measurement of even lowest Lower Limit of Quantification (LLOQ) addressing dosing and pharmacokinetic needs
• Dedicated laboratory: Exclusive wet-lab and instrumentation room
• Qualified Experts: Experienced team of scientists with proven expertise

What are some of the drugs and infections that you have dealt with for inhalation studies?

We have developed bioanalytical methods to measure, mometasone, fluticasone formoterol, albuterol, tiotropium, and Ipratropium. To date we have handled 10+ molecules.

Bioanalytical Methods Developed for

• Mometasone (1pg/mL)
• Fluticasone (0.5pg/mL)
• Formoterol (0.4pg/mL)
• Tiotropium (0.5pg/mL)
• Ipratropium (0.5pg/mL)

• Vilanterol (1 pg/mL)
• Budesonide (10pg/mL)
• Beclomethasone dipropionate and monopropionate (10pg/mL)
• Albuterol (20pg/mL)

How do you ensure the right aerosolization of the drugs for inhalation studies?

We carry out priming to ensure that the proper spray takes place, in a separate room. At the time of dosing, we ensure that the right quantity is administered.

The neck should be slightly lifted to the upper side to ensure proper opening of the trachea, so that the drug delivery is optimum.

The position of the tongue is also important, to prevent the tongue from obstructing the entry of the drug.

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