Thesis work: Accelerated dissolution of Oral Solid Dosage tablets

Job description
Thesis work AstraZeneca: Accelerated dissolution of Oral Solid Dosage tablets: comparing empirical results of dissolution rate with theoretical calculations

Aim
Evaluate dissolution rate for 3 immediate release tablet formulations at both normal conditions and with increased temperature and stirring speed. Compare the actual dissolution rate with theoretical calculations.

Place:
Sweden Operation AstraZeneca is the largest site in the world for the production of pharmaceuticals. The work will be carried out in quality control laboratory and production environment at Östertälje.

Responsibilities
Background
At quality control in the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, that is, to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and during drug development to predict in vivo drug release profiles. The procedure is time consuming and when performed manually very labour intensive. To increase the rate of dissolution, thereby shortening the experimental time, it is possible to increase the temperature and stirring speed. However, there are currently no commercial dissolution robots on the market where it is possible to increase the temperature substantially. AstraZeneca has fully automated dissolutions robot SingBATH that can run with elevated temperatures. The company use this in production where operators carry out dissolution of various pellet intermediates at standard temperatures. In this diploma work the SingBATH will be used to assess the possibility of accelerated dissolution rate for release of final tablet product and compare it with theoretical calculations.

A literature review should cover the theory of dissolution and the equipment - different apparatuses, manual and automated - that are approved for pharmaceutical release testing. Multivariate design of experiment will be used to create test protocols and evaluate results.

Instrument equipment
The SingBATH is a fully automated  USP apparatus 2 dissolution single vessel robot from Sotax. It is possible to queue up samples which means that the Robot can run over night with registered samples.

Experimental work
3 products with different solubility will be examined
To get calibration factors for each product calibration methods for the robot SingBATH will be created by modifying existing calibration methods.

A current dissolution method for SingBATH will be modified to work for each product. Standard conditions for dissolution is 37 degrees Celsius and 50 RPM. The conditions that will be varied to achieve accelerated dissolution rate is paddle speed and temperature.

Evaluation
Calculate average dissolution rate, standard deviation and relative standard deviation for all experiments. Compare data to theoretical calculations with respect to increased temperature when paddle speed is constant.

Software used in this diploma work:
Excel
SenISS
Minitab 
Simca/Modde

Qualifications
Essential Requirements
Master student in Chemistry, Chemical or Biochemical Engineering or Pharmaology is requirements of the role.
 
Desirable Requirements
• Like to carry out experiments in the lab
• Like to learn and master new softwares to automate experiments
• Like to work with excel templates for automatic reporting

Application
Deadline: 2022-03-13 , selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

Thesis type: 30 credits
Start: summer 2022

About AstraZeneca
At AstraZeneca we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

About the company
With more than 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry and offers staffing, consulting and recruitment solutions in all areas of expertise. We also offer interim management, executive search and outplacement services. We have a large network of clients and candidates, which means that we convey hundreds of jobs within different industries all over Sweden. Our ambition is to be the best employer in the market. 

By combining our passion for people with the power of today’s technology, we help people and organizations to reach their true potential. We call it Human Forward.