Product development

Development of medicines and placebo for clinical trials and for patients

Process

Development of formulations

Pre-formulation

The development of a new product/formulation for clinical trial starts with a physical-chemical characterisation of API (active substances), such as by determining particle size and particle size distribution, solubility and compatibility studies, and density measurement. Based on the results of these studies, we produce one or several composition proposals for preliminary stability studies.

Formulation of medicines and medical devices

Proposed formulations and manufacturing processes for medicine preparations and medicine-promixate products are developed. The proposals are based on the result of the pre-formulation studies and the desired product
characteristics

Preparation forms

The preparation forms we develop include:

  • Water solutions
  • Suspensions
  • Emulsions
  • Injection medicines
  • Topical gels
  • Creams
  • Capsule preparations

Development of analysis methods

Analysis methods

We develop and validate the physical-chemical and microbiological analysis methods used to characterise products and in stability studies. We base these on the
product’s characteristics and propose a suitable method before carrying out development and validation. All work is carried out according to the ICH guidelines.

Techniques

We work using techniques such as UPLC, HPLC, GC-fid, GC-headspace, HPLC-MS, GC-MS, IR, UV/vis, DSC, TGA and release analyses. We also have very long experience of wet chemical analysis according to pharmacopeia.

Stability studies

Product durability

To enable us to state product durability periods, we carry out stability studies to see how well they do over time and under differing conditions. We set up stability studies in climate rooms according to the ICH guidelines.

The scope of the stability studies is determined on the basis of the product durability required.

Pre-formulations, products in clinical trials and commercial products can all be put through stability studies.

analys

When the excipient and the active substance are of equal importance

Together with our customers, we develop and produce new medicines with particular product characteristics.

Contact

Visiting adress:

Prismavägen 2, Kungens Kurva

 

+46 10 447 96 00

info@apl.se

 

Other contact information

About APL

APL is one of the leading manufacturers of extempore pharmaceutical drugs in Europe. We are one of the leading contract manufacturer in Life Science in Scandinavia and an established partner to pharmacies for services and products. With our 489 employees and four production plants, we have resources for developing, analysing and producing drugs. APL contributes to medical products that improve or save lives.


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