Pharmaceutical Product Design and Development

Although you know your drug and you know your market you may not know the best way to deliver your drug to reach its commercial goals. Altus can design and deliver;

Simple Immediate Release (IR) Formulations for pre-clinical testing and lead selection. Altus can design and develop oral solutions, IR tablet and capsule formulations including multi-particulate formulations, orally disintegrating tablets (ODT), intranasal and intravenous formulations using either conventional or Altus Technology based approaches for increased value. Altus can rapidly transition such formulations to clinical supplies for First in Human studies.

Generic and Complex Generic Formulations for Bio-equivalence Studies. Based on our partners development needs, Altus can design and develop immediate release, extended release, pulsatile release and delayed release, single or fixed dose combination generic versions of existing products and scale these for clinical and commercial supply. Dosage forms include oral liquid formulations, ODT, direct compression film coated tablets, functional film coated tablets, immediate, extended or delayed release multi-particulate formulations.

Value Added Medicines. Altus can design and develop a range of Altus Technology based, oral liquid, and oral solid, intravenous and ophthalmic solution products with differentiating features covered by Altus Patent Umbrella for 505(b)(2) or 10(3) hybrid applications.

Enabling Formulations for Difficult to Deliver Drugs including Low Solubility Drugs and Low Stability Drugs.
Altus can design and develop differentiated IR and ER formulations which enable improved oral bio-availability, and or oral product to intravenous product repurposing. Altus can also design and develop
high penetration ophthalmic formulations to deliver your drug throughout the eye. All products will be covered by Altus Patent Umbrella.

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FAQs about Pharmaceutical Product Design

What is pharmaceutical product design?

The pharmaceutical product design (PPD) of a drug is a guideline used in every step of the drug development process. In other words, it is the objectives of the developed drug, and all the research and development aim to prove that the new product will efficiently and safely perform that role. This is a lengthy process that requires secured trial-and-error experimentation to ensure a company only brings safe products to the market. It can be summed into 5 main stages.

  1. Drug discovery – In the beginning stages, the active pharmaceutical ingredient, also known as API, needs to be determined. A substance or a combination of substances required to create medicine for a specific issue.
  2. Formulation design of the pharmaceutical product – Addition of other ingredients to stabilise the medicinal substances and create an efficient product.
  3. Design of the manufacturing process – This stage analyzes the best method of mass production of the medicine including the procurement of the ingredients.
  4. Delivery method design of pharmaceutical product – This is the process of determining the method of consumption of the product. For example, the medicine might be in the form of a tablette, injection, syrup, and many others.
  5. Approval and testing pharmaceutical product – Once the product has been approved it moves on to be marketed.
What is a Target Product Profile (TPP)?

If the development process is the road, the TPP is the final destination of a new drug. The TPP is a list of the desired characteristics of the developed drug, such as which disease it targets and from what segment of the population. Having a clear objective allows for an optimized development with the right formulations, trials and processes. The TPP also serves as a guideline for non-clinical and clinical trials, where the right tests can be done to access the right characteristics of the new compound and make it competitive once it reaches the market.

The Target Product Profile is a constantly evolving document, which is adjusted according to the different trials and studies performed. Overseeing this important aspect of the drug’s development is a task best suited for an experienced and competent group of experts such as Altus Drug Development’s team.