The Standard Group of Companies is a leading supplier of equipment in the pharmaceutical industry.
There are many key and critical processes in this industry, with Formulation arguably being the most important.
Formulation is the process in which different chemical substances, including the active drug or API, are combined to produce a final medicinal product.
The word formulation is additionally used in a way that describes the dosage form.
Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient.
For orally administered drugs, this usually involves incorporating the drug into a tablet or a capsule.
It is important and to make clear that a tablet contains a variety of other potentially inert substances apart from the drug itself, and studies have to be carried out to ensure that the encapsulated drug is compatible with these other substances in a way that does not cause harm, whether that be direct or indirect to the patient.
The drug essentially will be mixed with inactive products by a method that ensures that the quantity of drug present is consistent in each dosage unit.
The dosage should have a uniform appearance, with an acceptable taste and hardness that is not offensive to the person using it.
Formulation studies and clinical trials work hand in hand during pharmaceutical manufacturing.
There are 4 key stages in a clinical trial.
Phase 1 or Early stage Clinical trials.
This is for the first time that a new drug or treatment procedure is tested on humans and it is unlikely that formulation studies will be completed by the time early trials begin.
Phase 2 studies.
Once a drug proves to be safe for human use it is moved to phase 2 studies. The target for a phase 2 clinical trial is to determine the right dosage of the drug and to confirm it is safe.
Phase 3 Clinical trials.
Once the drug proves effective and safe previous studies, it is then moved to the phase 3 trial. These are long term trials that include a large population of participants.
By the time phase III clinical trials are reached, the formulation of the drug should have been developed to be close to the preparation that will ultimately be used in the market.
Phase 4 clinical trials or Advanced stage trials.
These studies are conducted on drugs or treatments that have already got approvals and are being prescribed by doctors.
Essentially these studies are basically done to collect extra efficacy data and market the drug as a better.
All of the above trials must be done in sterile and aseptic conditions with full containment being the optimum way of working.
The Standard Group of Companies manufacture and install Barrier Isolators for all formulation processes and proving the desired aseptic conditions.
Barrier isolators are supplied into 2 distinct categories:-
- Formulation Isolators – OSD (Oral solid dose)
- Formulation isolators - Injectable
Examples of OSD formulation barrier isolators:-
- Tablet press
- Tablet coat
- Blister pack
Examples of Injectable formulation barrier Isolators:-
- Powder filling
- PFS filling (Pre filled syringe)
- VHP sterilisation
For more information on barrier isolator selection click here or contact the UK and Indian offices directly.