Cassina de' Pecchi
The production site, opened in 1994, has over twenty years’ experience in the production of medicated patches containing diclofenac, fentanyl, nitroglicerine
and piroxicam. Since 2017 it has also been producing sildenafil in orodispersible film and in 2019 it has begun the production of nutraceuticals in ODF form too.
Orodispersible films (ODF) are among the productions with the highest technological and innovation content made at this production site: IBSA is one of the few European players that produces for both the pharmaceutical and nutraceutical sectors, thanks to its patented technology.
A second field of production with high technological and innovative content is that of medicated transdermal patches based on drug-in-adhesive technology, that allows the controlled release of drugs.
The production site is spread over 10,520 m2, including research and development laboratories, a quality control department and offices. The production and warehouse areas occupy 5,450 m2 and the plants 3,404 m2
More than 70 people work there.
Production is concentrated in the following technologies and pharmaceutical forms:
- Medicated patches
- Patches with natural active ingredients
- Patches for basic medication
- Orodispersible films (ODF)
Production capacity, calculated on an annual basis and by pharmaceutical form, is divided as follows
- Topical patches:
- Transdermal patches 15 mio units
- Orodispersible films 18 mio units
- Balsam patches 11.5 mio units
- Dressing 25 mio units
- Nutraceuticals on orodispersible film 10 mio units
Cassina site’s production serves both the IBSA Group and some multinational corporations, and directly supply various markets in addition to Italy, such as France, England, Hungary Slovakia, the Czech Republic, the Baltic Republics, Scandinavia, EMEA and South America.
The production site has the following certificates and authorisations:
- Quality Management Systems: UNI EN ISO 9001:2015 (Certiquality) - Eu GMP
- Medical Devices: Quality Management System - Requisites for regulatory purposes (UNI CEI EN ISO13485:2016) (Certiquality)
- AIFA authorisation and manufacturer’s GMP compliance certificate
- (Directive 2001/83/CE and Leg. Decree 219/2006) for:
- production, primary and secondary packaging, control of non-sterile medicinal products (“impregnated matrixes”, transdermal patches,
- production activity for non-sterile experimental medicinal products (“impregnated matrixes, transdermal patches, orodispersible films)
- Authorisation for the use of narcotic and psychotropic substances (Presidential Decree 309 dated 09/10/1990)
Transdermal patches, both single - and multi-layer, are produced at the Cassina de’ Pecchi production site. They are based on drug-in-adhesive technology and designed to act both locally and systemically, depending on the action site of the active ingredient.
Both types are protected by patent.
- reduce side effects
- increase tolerance to drugs thanks to the gradual absorption of the active ingredient
- are easy to handle and small in size
- are thin, cosmetically acceptable and easy to use
IBSA currently produces and commercialises patches containing nitroglycerine, diclofenac and other active ingredients, both for local and systemic release.
Patches containing piroxicam, diclofenac and fentanyl are already commercialised by our client companies.
IBSA has also developed patches for dermatological chemotherapy, while products for application in other therapeutic areas, such as cardiovascular, dermatological, neurodegenerative syndromes and pain therapy are currently being developed.
Production method for drug-in-adhesive patches
- mixing of all the ingredients to obtain the adhesive liquid mass
- spreading, drying and lamination of the liquid mass
- cutting the lamina into small rolls
- punching of patch edges
- sealing of patches into single bags
Cosmetic and free-sale patches
- Patches with natural active ingredients (for example: mountain arnica, achillea, peppermit, lavander for its warming and soothing effect, caffeine for its slimming effect)
- Patches with essential oils (oils extracted from medicinal herbs and plants that are decongestants and used for aromatherapy)
- Keratolytic patches (with salicylic acid, having keratolytic action to reduce thickened areas of skin)
Patches for basic medication
The production site can also make patches in different sizes for basic medication in the following supports:
- classic 3D support with three-dimensional perforation
- non-woven fabric support – sensitive
ORODISPERSIBLE FILM (ODF)
At the same site, with ODF technology, IBSA has developed what can be defined as a new frontier of pharmaceutical innovation.
This innovative oral pharmaceutical form dissolves in just a few seconds, making the active ingredient rapidly available for absorption by the oral mucosa or systemically.ODF technology has been found to be useful in patients of all ages and was recently applied to anti-inflammatories, painkillers and antihistamines too. Since 2019, orodispersible film production has also included the production of nutraceuticals, thanks to the creation of a specific department with dedicated machinery inside the production site.
The industrial process comprises various phases:
- preparation of the mass
- preparation of the film
The production site, acquired by IBSA Group in 2001, produces injectables, both in asepsis and with end sterilisation, in traditional ampoules and in pre-filled syringes, topical preparations (creams, gels, solutions) in BoV, soft capsules (Softgels) for pharmaceutical and nutritional use.
The site covers a total area of 11,815 m2, including production departments, raw materials warehouse, sampling and dispensing areas, research and development laboratories, chemical and microbiological laboratories for quality control and offices. The pharmaceutical production area and the warehouse occupy 5,415 m2 while the nutritional production area and warehouse occupy 966 m2. 185 people work in the production site.
Specifically, production is concentrated on the following pharmaceutical forms:
- traditional ampoules and pre-filled syringes in aseptic conditions
- traditional ampoules and pre-filled syringes sterilised terminally
- liquid and semi-solid forms (creams, gels, liquid solutions, also in BoV)
- oral forms: soft capsules (Softgels)
- primary and secondary packaging
Production lines at the plant, which produced approximately 23.5 million items in 2017, are cutting-edge in terms of technology and environmental sustainability thanks to sizeable investments made over the years that have maintained the plants at a high efficiency level.
Production capacity, calculated on an annual basis and by pharmaceutical form, is divided as follows:
- Traditional ampoules: 15 mio units
- Aerosols (BoV): 6 mio units
- Tubes: 2 mio units
- Pre-filled syringes: 19 mio units (15 mio Bosch units)
- Soft capsules for pharmaceuticals: 160 mio units
- Soft capsules for nutraceuticals: 130 mio units
Productions from the Lodi site, in the form of semi-finished and finished products, serve the entire IBSA Group and directly supply various markets in addition to Italy, such as France, Switzerland, England, Hungary, Slovakia, the Czech Republic, Greece, Spain, Scandinavia, Russia, Egypt, Turkey and the USA.
The production site is authorised by AIFA for the pharmaceutical productions already stated and is subject to periodical two-yearly inspection.
The site is therefore GMP certified.
The Quality System is certified to ISO 9001: 2015 and ISO 13485:2016 (TUV Sud) standards.
Nutraceutical production is authorised by the Ministry for Health and supervised by the Regional Health Authority.
SOFT CAPSULES (SOFTGELS)
The production site has two departments for the production of soft gelatine capsules, both for pharmaceutical and nutritional use (food supplements).
The technology allows oils, pastes, viscous substances and suspensions to be incapsulated in a gelatine coating.
This administration form is particularly important in the presence of active substances in oil form and of solid substances with low solubility and/or permeability in water.
Soft capsules allow these active ingredients to be taken, improving patient compliance, and at the same time relieving the sensation of taste or smell when taken.
The capsules are made using an exclusive technology, that brings together two fluid gelatine films on two cylindrical moulds with hollows, that rotate in opposite directions to each other and at the same time as forming the capsule, inject the solution containing the active substances using a precision volumetric pump.
The last phase of the manufacturing process is the drying of the gelatine wrapping, which is soft and fragile when the capsule is formed.
Softgel technology allows both drugs and nutraceuticals to be formulated and made: the wide range of formats and colours satisfies all client needs.
CREAMS, GELS AND SOLUTIONS FOR TOPICAL USE
The production site has a production line for creams, gels and aqueous solutions packaged in aerosol sprays with Bag-on-Valve(BoV) technology.
The Bag-on-Valve system comprises a pressurisable aluminium aerosol containing a multilayer material bag (polythene aluminium) onto which a nozzle valve is assembled.The product is placed inside the bag and the space between the bag itself and the bottle is pressurised with compressed air.There is therefore no direct contact between the propellant and the product.When the nozzle is pressed, the product - forced by the pressure on the bag - pours out of the aerosol bottle.
In alternative to the Bag-on-Valve, topical products can be dosed in traditional aluminium tubes, sized from 25 to 100 grams.
The Lodi production site produces injectable formulations, in both aseptic conditions and with terminal sterilisation, under the form of:
- traditional ampoules from 1 to 5 ml
- pre-filled syringes from 1 to 3 ml filled with high and low viscosity products for intra-articular and intradermal use.