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TRADICHEM INDUSTRIAL SERVICES

Solutions for the pharmaceutical industry

tis farma logo

TRADICHEM INDUSTRIAL SERVICES

Compaction and Granulation Hipering Technology

tis farma logo

TRADICHEM INDUSTRIAL SERVICES

Industrial platform GMP

We customize APIs according

to the industrial needs of the final product manufacturer.

About

At TIS Pharma we develop API compression and granulation processes for third parties to improve production efficiency through our Industrial GMP technology..

We provide a pharmaceutical service for the physical transformation of raw materials, keeping purity intact. This translates into an increase in operational efficiency of up to 60% for manufacturers of final dosage forms and a consequent impact on the reduction of industrial costs.

We increase operational effectiveness by 60%.
Procesos

Custom APIs

After the API obtaining processes, many of these active pharmaceutical ingredients need compression and granulation stages so that they can be adapted to the manufacture of different final galenic forms. These APIs need to be pre-compacted to start the drug manufacturing process which, in many cases, are carried out using equipment which isn’t specifically designed for this process. This leads to a consequent cost in materials, man hours, loss of yields, manufacturing hours and other costs derived from this pre-compression

We carry out physical transformation processes of actives obtaining an improvement in critical parameters such as fluidity, density, particle size, homogeneity, solubility, volatility and hygroscopicity of the raw material. Hipering® technology allows optimization of the active ingredient according to the manufacture of the final product.

Our GMP industrial platform allows the control and standardization of batches of raw materials according to the industrial needs of each client; whether that’s at the level of the manufacturer of the active ingredient, or of the final pharmaceutical form.

fabricación

HIPERING® TECHNOLOGY Patented technology

Hipering® is a technology based on a sequence of processes that allow modifying the physical properties of each API while keeping its purity and chemical specifications intact.

The APIS are studied individually, carrying out various developments with the aim of improving each of their physical properties through an advanced dry compression-granulation process.

By means of standardization, it is possible to eliminate the variability of batches of APIs and to physically customize the pharmaceutical actives, dispensing with the costly and inefficient pre-compressing stages of APIS.

Patents:

  • EP3705475A1: HIGH-DENSITY L-TRYPTOPHAN, ITS PREPARATION AND USES THEREOF
  • EP3705117A1: MELATONIN HAVING IMPROVED WATER SOLUBILITY, ITS PREPARATION AND USES THEREOF.
  • 118925PEP: PROCESS FOR PREPARING COMPACTED COENZYME Q10 PARTICLES OF HIGH DENSITY AND IMPROVED FLOWABILITY (In process)
Slide 01
1

Initial shape (S)
ρ = 0,15 g/ml
Capsule size: 22 oblong

Slide 02
2

Ribbon (R)



Slide 03
3

Final shape (F)
ρ = 0,65 g/ml
Capsule size: 10 oval

BENEFITS OF HIPERING® TECHNOLOGY

HIPERING® TECHNOLOGY INDUSTRIAL BENEFIT
  • Reduction of adhesion of raw materials to equipment walls.
  • Higher flow rate.
  • It reduces the volatility of APIs.
  • Lower percentage of losses.
  • Higher performance and process speed.
  • Shorter cleaning times.
Density modification.
  • APIs suitable for obtaining lower volume final dosage forms.
  • Reduces the amount of packaging material and storage volume required.
  • Less use of excipients.
Control of hardness, porosity and geometry of the particles.
  • Optimal disintegration/dissolution of tablets and capsules.
  • Improved friability/hardness in tablets.
  • Galenically facilitates obtaining delayed/prolonged release forms.
Obtaining a homogeneous PSD. Obtaining homogeneous mixtures.
Solvents do not need to be added.
  • Maintenance of intact chemical/purity properties.
  • Avoids water-induced degradation products.
  • Does not require an ATEX equipment/fabrication room.
Replicability of a consistent and homogeneous particle size/density.
  • Facilitates continuous manufacturing.
  • Improves stability.
  • Avoids bulk segregation.
  • Improves content consistency in FDFs.
fabricación

Industrial Benefits

  • Increased productivity and performance: Our technology allows the physical modification of the raw material, keeping its purity and chemical specifications intact. This allows for the reduced use of excipients, a reduction in gelatin consumption, a reduction in packaging material and the costs associated with them.
  • High-density custom APIs Improving the physical properties of actives without modifying purity or chemical properties is not an easy process. At TIS, we have developed a patented technology capable of customizing each asset, without the need to include any type of solvent, excipient or other chemical product.
  • Access to new market segments The know-how of each ingredient and the optimization of the process allow us to obtain pure actives adapted to the specific demands of each client. At TIS we obtain direct compression APIs, APIs suitable for delayed/prolonged release dosage, etc.
  • Immediate incorporation into dossiers We obtain an identical analytical profile by HPLC compared to the original API. Our Hipering® technology is a process which is free of impurities in which the stability and the useful life of the asset remain intact ...
Procesos

Benefits for the consumer

  • Smaller galenic forms with the same dosage: We adapt the original API to reduce the size of the final dosage form, maintaining the same dose.
  • Same dosage in fewer capsules/tablets: The increased density of the active ingredients allows the necessary dose of API to be included per dose in a single tablet/capsule.
  • Avoid swallowing problems: By obtaining smaller galenic forms, it allows us to cover new market areas (the elderly, children) with worse swallowing issues.
  • Greater adherence to treatment: As a consequence of the reduction in the size of the unit doses and the number of capsules/tablets per dose, adherence to treatment is improved by the patient.
Productos Desarrollados
  • Allopurinol HD
  • Diosmin HD
  • Fenbendazole HD
  • Ibuprofen HD
  • L- Carnitine GR
  • L- Tryptophan GR
  • Melatonin WS
  • Metamizole HD
  • Metformin HD
  • Pantoprazole CP
  • Paracetamol HD
  • Sitagliptin CP
  • Solgen 40
  • Solgen 40G
  • Solgen 40J
  • Trimebutine CP
  • Troxerutin HD
  • Vinpocetine