A Fully Integrated Continuous Manufacturing System at Aprazer Healthcare
Aprazer Healthcare is a pharmaceutical manufacturer.
With the largest oral solid plant at Haridwar, we are capable of manufacturing different solid dosage forms.
We are equipped with end-to-end continuous manufacturing systems, processing the powdered forms to final coated tablets.
The Triad of Dosage formulation
A dosage form is as important as the drug itself.
A successful formulation delivers the drug safely and effectively to the site.
It includes an intricate process of-
- Consistent release
- Enhanced absorption
- Drug stability
Different types of Oral dosage forms-
- Tablets
- Capsules
- Powders and granules
The components of solid dosage formulations-
API – The active pharmaceutical ingredients.
It gives the therapeutic effect.
Excipients – These are the components used to blend with API.
It enhances its –
- Solubility
- taste
- stability
- shelf life
- compressibility
Finished product – the capsule or tablets that are consumable
Packaging – The tablets or the capsules are dispensed into sealable outer coverings to prevent degradation.
The critical steps involved in manufacturing solid oral dosage forms
Preformulation studies –
It is the investigational phase.
The physical, chemical, and biochemical properties of the API are studied.
It provides necessary data that helps excipient selection.
Compatibility testing –
It is the analysis of the interactions between the drug and the excipient.
The API mixture and the selected excipient are subjected to stress testing.
It is passed through analytical testing.
- HPLC
- Differential Scanning Calorimetry (DSC)
Prototype creation-
A small batch is prepared at laboratory scales.
It is tested for physical prototypes.
- Hardness
- Friability
- Dissolution
Stability and shelf life testing
It includes accelerated testing.
It is done to predict-
- Shelf life
- Long-term degradation
- Expiry date
Scaling up production
In this the operational parameters are adjusted.
- Compression force
- Mixing speed
- Drying times
It ensures batch-to –batch consistency and uniform API distribution.
Regulatory dossier preparation
It is the compilation of all the documents for regulatory approvals.
The operational stages include –
- Weighing /dispensing
- Milling/blending
- Granulation
- Drying /screening
- Compression/encapsulation
- Coating
Aparzer’s expertise in manufacturing oral dosage forms
Meeting the diverse needs of customers, we manufacture small batches to large volume productions.
Equipped with extensive granulation techniques, we are capable of manufacturing compressed tablets to complex dosage forms.
The types of oral dosage forms manufactured at Aparzer Healthcare includes-
- Uncoated tablets
- Film-coated tablets
- Modified release tablets
- Oral dissolving tablets
- Capsules
