Progress report-2 2011
Memo
To:
Prof.Caruso
From:
Group-6 Engl-250 section-75
CC:
Jaymin, Vasee, Ronak, Mohammad,Ravi
Date:
June 29, 2011
Re:
Progress Report 2 – Part 1: Research Product for Proposal
I am writing this progress report to provide you to inform regarding our research product doxorubicin
loaded liposomes that can be used in the breast cancer.
INTRODUCTION
LIPOSOMES:
They are artificially prepared vesicles made of lipid bi layer; liposomes are usually loaded with drugs
and used to treat cancer and other diseases. So basically liposomes are artificial cells.
1
Progress report-2 2011
They are generally prepared by adding the phospholipids in water. The process of production of
liposomes is not complex and to incorporate the drug in them is also easy.
TREATMENT OF BREAST CANCER:

Conventional treatment of breast cancer includes standard treatment options like surgery and
chemotherapy.

Side effects with conventional treatment of breast cancer- The side effects, such as hot flashes
and depression occur when treated for breast cancer. Hot flashes are when your brain sends
signals for example you cannot tell if it is hot or cold; some women may experience
headaches, feel weak, dizzy, tired. Moreover, chronic side effects include bone marrow
suppression which leads to depressed production blood cells from the bone marrow.
PLAN OF RESEARCH:
We are planning to research more on the drug Doxorubicin and find ways around it without the
patients having any side effects or other kind of life threatening adverse drug reactions due to drug
dosing. Doing this will achieve in a more successful result rate with women who have breast cancer,
as they will not have any side effects when they take our newly developed drug dosage form.
BACKGROUND
The idea of our project is to develop a target drug delivery system for breast cancer in such a way that
we get the maximum benefits of drug and to avoid the major side effects. In cancer chemotherapy, the
major problem is patients have to suffer from the side effects like hair loss, bone marrow suppression
and many others. Our interest is to made doxorubicin loaded liposomes particles to target the breast
cancer condition and made it available even for the industrial production. Industrial production of a
particular dosage form is very hard process in which you have to follow all the standards as well as
dosage form design process. The recent data on breast cancer are shocking and one can easily
visualize that nowadays breast cancer is becoming the common disease as it was not in the past. From
2004-2008, the median age at diagnosis for cancer of the breast was 61 years of age. Approximately
0.0% was diagnosed under age 20; 1.9% between 20 and 34; 10.2% between 35 and 44; 22.6%
2
Progress report-2 2011
between 45 and 54; 24.4% between 55 and 64; 19.7% between 65 and 74; 15.5% between 75 and 84;
and 5.6% 85+ years of age. The age-adjusted incidence rate was 124.0 per 100,000 women per year. It
is estimated that 207,090 women will be diagnosed with and 39,840 women will die of cancer of the
breast in 2010 (U.S. National Institute of Health, 2010). These data clearly shows the need of a
versatile dosage form which is easy, convenient and free from major adverse effects.
The objectives of our project are to design a target drug delivery system for cancer therapy in
such a way to have maximum benefits of the drug molecule. The expected outcomes of the projects
will be tangible as well as intangible. Tangible benefits includes the easy of production of the dosage
formulation, less production cost, no more investments in researching the new drugs to cure a
particular disease. Whereas, Intangible costs includes the health benefits to the patients. The method of
production of liposomes is easy because the initial costs i.e. the raw materials come in variety of
different categories. It comes in range from 10 cents to 1 million dollars. Production of liposomes is
not a sole concern. We have to select a particular dosage form in which we can incorporate the
liposomal particles so we are going select soft gelatin capsules to incorporate the liposomes in it.
PROPOSAL PLAN
PROJECT DETAILS:
Our project is mainly based on for different steps which collectively yield us the success. The major
steps in the project are as follows:
1. Preparation of liposomes:

Liposomes are prepared by dispersing lipid particles in the water or other organic solvents like
alcohol and ether which evaporates quickly and produces the liposomes.

Preparation liposomes can be carried out by using two different methods:
(a) Lab scale method: This utilizes polyol as the organic solvent to disperse the lipid phase.
(b) Large scale manufacturing: In this method, sonication process is used.

Sonication is the process of applying the ultra sound energy. This process requires instrument
named as Sonicator.
2. Incorporation of drug molecules:

Incorporation of the drug into the liposomal particles is the easy process.

Drug solution is prepared using the suitable solvent and then the solvent is added to the
solution from which the liposomes are going to prepare.
3
Progress report-2 2011
3. Designing a dosage form and product evaluation:

We select the hard gelatin capsules as a drug carrier to the body.

Hard gelatin capsules offers several advantages over other dosage forms like they are easy to
handle, easy to produce in large quantities, available in variety of sizes that carries drug from
600 micrograms to 30 milligram.

The list of equipments that are necessary for the production of the hard gelatin capsules
containing the liposomes is given in the sheet attached at the end of the report.
4. Marketing of the dosage form:

This is the most complicated phase in the project.

We are targeting different populations like medical and health care professionals as well as
women between 20 to 50 years who suffers from the breast cancer.

For marketing of the dosage forms, we are thinking to recruit various medical representatives
who will take our products directly to the doctors who prescribe the medications.

After product comes to the market, another main aspect that we have to take in consideration
is the post marketing surveillance.

Post marketing surveillance is necessary for the drug formulations because many adverse
effects may come after a year of the drug has been in the use. This may need the product
modifications.
4
Progress report-2 2011
PROJECT SCHEDULE
DATES
WORK
TEAM MEMBER
INVOLVED
July 6,2011
Gathering of the information
Mohammad and Ronak
regarding methods for
production and storage
conditions
July 13,2011
List out the equipments and
Ronak and Vasee
materials that are needed to
prepare the liposomes
containing drug
July 20,2011
Preparation of liposomes and
Ravi and Jaymin
preclinical testing
July 27,2011
Clinical testing to check the
Ravi and Ronak
effectiveness and development
of the marketing strategies
August 3,2011
Marketing of the dosage form,
Jaymin and Mohammad
post marketing surveillance and
product modifications if needed
REPORTING SCHEDULE
5
REPORTS
DATE OF SUBMISSION
Progress report
July 13,2011
Formal report
July 27,2011
Oral report
August 3,2011
Progress report-2 2011
LIST OF EQUIPMENTS REQUIRED:
1. Sonicator
2. Microfluidizer
3. Sterilizer
4. Homogenizer
5. Temperature regulating devices
6. Fluidized air drier
7. Capsule production and drying unit
6