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Delim – Overview
Headquartered in Milan, Delim Cosmetics & Pharma s.r.l., has established itself within under 20 years as a dynamic and innovative Contract Research Organisation (CRO) specializing in the development of novel drugs formulations and generic pharmaceutical products.
Delim specializes in the design, patenting, and technical transfer of innovative and generic pharmaceutical products, such as eye-drops, semi-solid gels, creams, and ointments for topical use, as well as OSD (oral solid dose) drugs, including immediate and modified release formulations.
Sustained growth
Delim Cosmetics & Pharma was founded in 2008 by owner and CEO Celestino Ronchi. The company has remained aligned on the mission to offer a suite of highly advanced B2B services to companies that need innovative technical/scientific support for the development of pharmaceutical products in compliance with latest international guidelines.
The company’s growth has been accelerated by a series of important contracts with scientific advisors, API manufacturing companies, contract manufacturing and clinical research organizations and it now operates a separate laboratory facility dedicated to formulation development and analytical control on new premises located in the northeastern Milan suburb of Vimodrone.
End to end support
The Delim Vision is of end-to-end support for clients through all stages of product development up to tech transfer, leveraging Quality by Design (QbD) and Design of Experiments (DoE) methodologies with deep knowledge of MVA software.
Its services include assistance for: patenting, sourcing of active ingredients (), development of prototypes, clinical trials. Also, assistance for: scale-up of manufacturing methods, tech transfer to GMP facilities, production of pilot, validation and bio batches, regulatory consulting and preparation of dossiers for pharmaceutical products registration.
Delim’s collaborations with academia, including Harvard University and universities in Brussels, Bologna, Milan, Parma, Shanghai, and its network of associates allow it to offer an internationally focused suite of services to assist pharmaceutical companies wishing to license their products for the European, North American, and LatAm markets.
Its in-house specialist expertise takes in development of semi-solid innovative and generic formulations (Q1, Q2, Q3), solid oral formulations for both immediate release and controlled release through technologies such as fluid bed coating and spray drying, in vitro studies of semi-solid products for topical and ophthalmic use, and development and validation of analytical methods in liquid chromatography.
Service areas
Delim’s principal service areas are:
- Pharmaceutical development of Finished Dosage Form
- Design of pharmaceutical products for alternative routes of administration of both known drugs and new chemical entities
- Patenting support for innovative formulations
- QbD development for oral and topical formulations and medical device from preliminary phases to pharmaceutical development report
- Assistance for cGMP production from tech transfer to optimization of industrial processes
- Analytical studies (set up and validation)
Delim Technologies
Delim technology portfolio covers a broad range of therapeutic areas and delivery systems that include:
- Dermatology: topical gels, emulgels, ointments, foams and creams containing corticosteroids, antifungal, anti-inflammatory, antibiotics, disinfectants, hormones, retinoids, anti-acne, antiviral, anesthetics, anticancer;
- Gynecology: vaginal gels and rings, creams, soft gelatin capsules containing hormones and antimycotics;
- Pneumology: dry powder formulations (DPI) for single and multidose inhalation. Among the main products developed we can list: tiotropium bromide, budesonide, budesonide formoterol, fluticasone salmeterol and indacaterol;
- Oncology: FDF intended for oncology therapies (tablets, ODF, and injectable solutions). Among the products developed we can list: Tamoxifen, Flutamide, 5-Fluorouracil, and Everolimus;
- Ophthalmology: FDF both in solution and in microemulsions. Among the products developed we can list: latanoprost and cyclosporine.
Delim also specializes in formulations for Medical Device, covering application areas such as Orthopedics (intra-articular lubricants in pre-filled syringes), Ophthalmology (preservative-free sterile Eye-drops in single dose and multi dose packages), Gynecology (lubricating and mucoadhesive gels and pessaries with dispensers), and Aesthetic Medicine (medical device formulations based on use of sodium hyaluronate including fillers and sterile solutions in pre-filled syringes).
Additionally, Delim has developed an innovative and patented technological platform for development of thermo-sensitive products intended for the mucous membranes in buccal (artificial saliva), vaginal (mucoadhesive moisturizing gels), rectal (enema), and bladder (mucoadhesive solutions) applications.
Resources
Click on Delim Company Profile for further information.
Delim specializes in QbD and analytical methods development of generic and innovative formulations for oral, topical, and systemic use.
