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Alpex Pharma

High-Quality Formulation Development and Manufacturing

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Alpex Pharma

Alpex Pharma provides production and research and development (R&D) of orally dispersible tablets (ODT) such as fast-melt and effervescent types.

The company has developed a unique proprietary covering ODT technology. High-manufacturing capacity and advanced R&D technology make Alpex Pharma one of the most important companies in the world in the field of fast-melt and effervescent tablets.

Alpex Pharma has state-of-the-art manufacturing and R&D facilities covering 7000m2.

Development and manufacturing of pharmaceutical and nutritional products

Alpex Pharma is a drug-delivery company that develops improved pharmaceutical products using proprietary technologies and extensive knowledge, developing and producing pharmaceutical products in the form of effervescent tablets and fast melt (ODT) tablets for various third parties.

Effervescent product manufacturing

Effervescent products are based on a chemical incompatibility between bicarbonate and an acidic source. The reaction is an autocatalytic reaction catalysed by the presence of water and heat, that generates CO2 in solution.

The control of the reaction is made by a strict control of the residual amount of moisture during the process and on the final dosage form (tablets).

orally dispersible tablet production

Advanced patented technology based on:
wet granulation of drug and excipients in a fluid bed granulator; moisture control during the process and in the manufacturing area; tabletting and packaging.

  • High drug loading: from a few micrograms up to 400-500 mg per tablet.
  • Effective taste masking and wide application.
  • Patent Protection: The fast melt patent issued in the US in 2000, and is pending in other countries

Development

Alpex Pharma produce pharmaceutical products in a completely dedicated area having also undertaken extensive development activities for third parties. They also identify product opportunities and develop them internally in view of finding interested licensing partners.

The Aplex Pharma development plan includes:

  • Drug-excipient compatibility studies
  • Analytical method development
  • Definition of formula
  • Cleaning development
  • Non-pivotal stability studies and reporting.
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Contact

Alpex Pharma SA
Via Cantonale
6805 Mezzovico (Lugano)
Switzerland
Tel: +41 91 935 51 10 operator
Fax: +41 91 935 51 20
Email: contact@alpex.com
URL: www.alpex.com

Alpex Services

Alpex Pharma is a drug delivery business focused on the development and commercial manufacature of effervescent and propriety rapidly dissolving (fast melt) pharmaceutical and nutraceutical products.

High quality service offering with strong oral solids technology platformsContract developer and manufacturer of orally-administered Drugs and Nutritional products:Effervescent productsOrally disintegrating tablets (ODT)Extended release tabletsGranular in sachetsWide geographic scope: Europe, US, South America, Asia and Australia - reputation for qualityBroad range of capabilitiesFormulation developmentScaling-upManufacturing of clinical batchesManufacturing of regulatory batchesAnalytical development (chemistry and microbiology)Validation of…

Clinical Supplies Manufacturing and Packaging

Contract manufacturingEff. TabletsRegular TabletsCoated TabletsGranulars in SachetsUnder Vacuum OvenClinical Manufacturing , Packaging and LabellingSolids - Effervescent Tablets - Regular Tablets - Coated Tablets - Hard Gelatin Capsules - Soft gelatin CapsulesSemi-solid - Gels - Creams - LotionsLiquids - Syrups - Oral drops - ParenteralsAnalytical Equipment and InstrumentationAtomic Adsorption AASGas Chromatography CGHigh Pressure Liquid Chromatography HPLCFourier…

Contract Manufacturing

MEGGLE is contract manufacturing various products for their customers also. With a broad spectrum of effort and state-of-the- art production equipment, MEGGLE is able to realize customer requirements quickly, reliably, and with the highest technical level.

Quality Standards: ISO 9001:2008, ISO 14001:2004, FAMI-QS, HACCP, IPEC GMP, Process-and Cleaning Validation for pharmaceutical products possible.Production Equipment:Eight Spray-DryerFive Fluid bed dryerTen EvaporatorService:Spray-dryingAgglomeration/dryingEvaporation   Modern spraytower with an external fluidized bed drier. The equipment and process is qualified according to current GMP guidelines.

Microbiological Services

Water System Validation for Purified Water ( EP, USP; etc. ) and Steam SystemsEvaluation of RequirementsGeneration of ProtocolsTraining in the Sampling TechniquesMicrobial Counts - Total Count - Bacteria - Yeast and Mold - Anaerobes - Coliforms, Fecal Enterococchi, Pseudomonas aeruginosaLAL TESTEP, USP ChemistryIdentification of MicroorganismsPreservative Efficacy Evaluation and ValidationPreparatory Testing / BioburdenCompendial Testing Support for…

Regulatory Affairs Consulting

Pharmalink spans the entire healthcare vertical.

Our job is to work with our clients to get their pharmaceutical products to market and keep them there. Very often, a client simply doesn't have the time to complete the work. That's where our Consulting services help. From an hour's work with one consultant, through to major, multi-national projects involving large teams of consultants,…

Stability Management Services

State of the art Facilities More than 40 sq.m of storage capacityDedicated area for stability studiesMonitoring of incubation conditions 24h/day, 7 days a weekRemote alarm systemA full range of storage conditions according to ICH requirements -20°C5°C25°C; 60% RH30°C; 65% RH30°C; 75% RH40°C ;75% RHPhoto stability testingThermal shockSpecial conditionsFull materials capability Active drugs Substances.ExcipientsSolidsSemi-solidsLiquidsOintmentsSuppositoriesParenteralLyophilized productsTransdermalAerosolsComplete Analytical…

Technology Platform

Including: Effervescent tables, effervescent granular in sachet, granular in sachets, orally disintegrating tablets, extended release tablets and soft gelatin capsules.

Effervescent Tablets (ET)Body hydration (200 ml of water)Buffering of stomach (Sodium Bicarbonate & citric acid)Stomach adsorption promotedTablets self-dissolvingAPI loading up to 2.5 g/tabletDifferent diameter (mm 18, 20, 22, 25)Flavoring possibleColoring possibleDifferent packaging (Tube, Blister, Strip)Effervescent Granular in Sachet (EG)Effervescent Granular in Sachet (EG)Body hydration (200 ml of water)Buffering of stomach (Sodium Bicarbonate & citric acid)Stomach…
Quick Contact Alpex Pharma
Quick Contact Alpex Pharma


Quick Contact Alpex Pharma
Quick Contact Alpex Pharma
Quick Contact Alpex Pharma


Contact Alpex Pharma

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