It is not easy to understand how a permeation study price is composed.

How much does it cost a Permeation Study?
Estimating the Budget for Developing
Effective and Compliant Products

and reach new customers with your products.

As a sponsor, you may have concerns about the cost of permeation studies and the potential for budget errors. The problem is that most companies are often reluctant to share their pricing policies.

At Technology Scientific, we understand the importance of transparent and comprehensive cost breakdowns, and for this reason, we have prepared this guide to explain how laboratories calculate permeation study prices. So that you can make the best-informed decision and get the most out of your investment.

Understanding the four components of a permeation study and how they influence the final price

Labour

The activities needed for a permeation study include: bibliographic research, procurement, handling and preparation of materials and samples, test setup, material data collection, analysis, material discard, report writing and delivery. It often accounts for a significant portion of the overall expense. The expertise and experience of the personnel involved also influence the labour rate. In a simple study without validation with ex vivo membranes for 1 analyte and 1 formulation it may contribute to the 35-45% of the final price.

Equipment

Most of the permeation studies require Franz cells, a thermostatic system, a chromatographic method and standard labware. Sometimes, more specialized instrumentation is necessary for the detection, as for instance, special HPLC columns or a more sophisticated gas-chromatography coupled with mass spectroscopy (GC-MS). In the latter case, the costs associated with the equipment have a significant impact on the final price. In a simple study without validation with ex vivo membranes for 1 analyte and 1 formulation it may contribute to the 20-30% of the final price. If special equipment is required it can increase its contribution up to 50-60%.

Materials

The materials involved in a permeation study or IVPT are samples and consumables. The samples refer to the product and the pure compounds used as standards, while the consumables refer to either the chemicals (solvents, acids, bases, buffers, reactants, and others) and the membranes. The cost of samples and chemicals usually has a marginal incidence on the study, while the membranes can significantly influence the final price. The membranes are the core of the whole study and can be either artificial (cheaper but less representative) or ex vivo (more expensive and more representative). Among the ex vivo membranes, the humans are more expensive than animal ones. Among animals, swine ones are the most expensive and more rappresentative. The choice of the membranes has to be driven by the goal of the study. During formula development, artificial membranes could represent a budget option. Ex vivo swine membranes better suit the requirements for product approval. Finally, IVPT studies for bioequivalence require human membranes. In a simple study without validation with ex vivo membranes for 1 analyte and 1 formulation, sample and chemicals may contribute to the 10-15% of the final price, while the membranes for a further 15-30% and in case of an IVPT up to 50%.

Overhead

It refers to facilities expenses, such as laboratory fees, utilities, administrative expenses and insurances, which also contribute to the overall cost of permeation studies. These costs are often allocated as a flat rate proportional to the time the facilities are dedicated to the study. They are calculated as 5-10% of the final price.

Saving resources and avoiding mistakes

Now, with a clear price breakdown you can effectively transform the permeation study from a cost to an investment. To do so you need to define what is the study goal and distinguish it from the objective. The goal is the gain you aim to earn with the permeation study. The objective is the experimental value from the study that will allow you to achieve your goal. The goal must be defined in the early stage and may refers to:

Increase of efficacy

To develop a product with higher efficacy than competitors.

Regulatory

To get the product authorization for commercialization.

Market confidence

Increase the market confidence for the product efficacy

Optimizing your permeation study

Highly effective formula

When developing a product, the objective is to compare the performances of several formula in similar release environment. Higher is the number of formulation prototypes tested higher is the probability of developing a product that surpasses your competitors. In this case, validation and ex vivo membranes can be traded for higher number of formulas tested.

Product authorization

When writing a technical file for product authorization, the main objective of the permeation study is to have an in vitro model representative of an alive biological organisms. This type of studies requires ex vivo membranes and validation of the protocol.

Increase the market confidence

When you want to increase the costumer awareness of your products, to prove how effective they are through laboratory testing is one of the most authoritative communication strategies. In this case the design of a permeation study depends on the final target and the communication channel used to reach your costumers. If you are aiming for an online campaign directed to the final users, a study similar to that for development may be enough. If you are aiming for a more competent audience, as sector professionals able to understand the data presented, publishing your data in a scientific peer-reviewed journal may be the most preferred option. If this is the case, the study should be similar to those for product authorization.

Final factors to consider

Once you have cleared the goal and the objective, you can move to refine specific factors as: 

Number of Analytes: It refers to the substances being tested for permeation, and it substantially influences the overall price. For each substance, the solubility and the relative “sink conditions” need to be established, and a calibration curve needs to be built. Analysing multiple analytes in one study certainly increases the price but also offers the possibility of working in series, allowing a reduction of labour and resources when compared to multiple separate studies.

Number of Formulations: It refers to the number of dosage forms with similar formulations to be tested for the same analytes. The incidence of additional formulations is higher than additional analytes since these are mixtures of compounds and thus the intricacy of the formulation may make difficult to separate the compounds with sufficient resolution, and may require specialized techniques, expertise, and additional analytical methods, leading to higher costs.

Study Duration: depending on the test parameters, permeation studies can be very time demanding. If the number of analytes and formulations is low, it would be eventually possible to compress the time. This is possible increasing the number of operators to carry as many task in parallel as possible, which sensibly increase the price

Analytical Methods: The analytical methods employed to quantify the permeating substance can also affect the overall cost. Specialized analytical techniques, such as high-performance liquid chromatography (HPLC) or gas chromatography-mass spectrometry (GC-MS), may be necessary for certain analytes or sample matrices, increasing the expense compared to standard methods.

Regulatory Requirements: In regulated industries, such as supplements or pharmaceuticals, permeation studies must adhere to ICH and OECD guidelines, which can add to the cost due to compliance testing, documentation requirements, and potential third-party consultancy.

Technology Scientific in vitro
permeation testing is used by
top companies and startups

Permeation study Packages Pricing

Every study includes

  1. Bibliographic research experimental protocol.
  2. Design, according to OECD guidelines.
  3. Franz cell selection, cell geometry.
  4. Membranes, artificial or ex vivo (animal).
  5. Test execution and permeation evaluation.
  6. Drafting of the report and delivery.

Development

1 analyte in 1 formulation

€ 3000

Updates: in real time

Email support: unlimited

Validation

Mobile assistence

VIDEO ANALYSIS OF THE REPORT

Express delivery

Most requested

Evaluation

3 analytes in 1 formulations

€ 5799

Updates: in real time

Email support: unlimited

Validation: according ICH

Mobile consultancy: 30 minutes

VIDEO ANALYSIS OF THE REPORT

Express delivery

Most requested

Line

6 analytes in 2 formulations

€ 8599

Updates: in real time

Email support: unlimited

Validation: according ICH

Mobile consultancy: 30 minutes

VIDEO ANALYSIS OF THE REPORT

Express delivery

Most requested

Express

7
Working
Days

1 analyte in 1 formulation
1 analyte in 1 formulation

€ 7199

Updates: in real time

Email support: unlimited

Validation: according ICH

Mobile consultancy: 30 minutes

VIDEO ANALYSIS OF THE REPORT

Express delivery

Most requested

Development

1 analyte in 1 formulation

€ 3000

Updates: in real time

Email support: unlimited

Validation

Mobile assistence

VIDEO ANALYSIS OF THE REPORT

Express delivery

Most requested

Evaluation

3 analytes in 1 formulations

€ 5799

Updates: in real time

Email support: unlimited

Validation: according ICH

Mobile consultancy: 30 minutes

VIDEO ANALYSIS OF THE REPORT

Express delivery

Most requested

Line

6 analytes in 2 formulations

€ 8599

Updates: in real time

Email support: unlimited

Validation: according ICH

Mobile consultancy: 30 minutes

VIDEO ANALYSIS OF THE REPORT

Express delivery

Most requested

Express

7
Working
Days

1 analyte in 1 formulation

€ 7199

Updates: in real time

Email support: unlimited

Validation: according ICH

Mobile consultancy: 30 minutes

VIDEO ANALYSIS OF THE REPORT

Express delivery

Most requested

Development

1 analyte in 1 formulation

€ 3000

Updates: in real time

Email support: unlimited

Validation

Mobile assistence

VIDEO ANALYSIS OF THE REPORT

Express delivery

Most requested

Evaluation

3 analytes in 1 formulations

€ 5799

Updates: in real time

Email support: unlimited

Validation: according ICH

Mobile consultancy: 30 minutes

VIDEO ANALYSIS OF THE REPORT

Express delivery

Most requested

Line

6 analytes in 2 formulations

€ 8599

Updates: in real time

Email support: unlimited

Validation: according ICH

Mobile consultancy: 30 minutes

VIDEO ANALYSIS OF THE REPORT

Express delivery

Most requested

Express

1 analyte in 1 formulation

7
Working
Days

€ 7199

Updates: in real time

Email support: unlimited

Validation: according ICH

Mobile consultancy: 30 minutes

VIDEO ANALYSIS OF THE REPORT

Express delivery

Most requested

Take the quiz below and find out now what is the best permeation package for you

What is your primary goal for this permeation study?

If you are developing a new formula and want to test the efficacy of the portotypes, or

if you want to increase customer product confidence with scienbtific data,

you can save time and money with a standrd protocol.

Formulating a new product

Writing a technical file

Building the product trust

How many analytes do you need to test?

If you have a tentative number of analytes to test, move the sliders to the corresponding range.

If you know the exact number of analytes, overlap both sliders to the corresponding number.

How many formulations do you need to test?

If you have a tentative number of formulations to test, move the sliders to the corresponding range.

If you know the exact number of formulations, overlap both sliders to the corresponding number.

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With Technology Scientific in vitro permeation studies,

your products will reach your
customers faster