Applications overview
Solid dosage forms
Tablets, Capsules, Sachets, Powders, Granules, Starch strips
Fillers - Diluent-binders for direct compression
Direct compression is a process that is becoming increasingly more important. Compared with wet granulation, direct compression requires less industrial equipment and allows productivity to be improved. Excipients for direct compression need to have good flowability, excellent compressibility and a specific particle size distribution to ensure uniform mixing.
Roquette proposes a remarkable varied range of products suitable for the formulation of all types of tablets:
- Starches or starch compounds for swallowable / dispersible tablets. They include some of Roquette’s newest developments:
- StarLac®: an innovative lactose-starch compound with unique tabletting properties
- LYCATAB® C: a multifunctional starch excipient for capsules and tablets
- LYCATAB® Mineral: a directly compressible excipient easy to use in mineral supplements.
- Direct Compression Maltodextrins for robust and suckable tablets with excellent smooth texture
- Polyols with their outstanding combination of chemical stability and great tasting and sugar free properties:
- NEOSORB®sorbitol powder with its characteristic sweet and cool taste is ideally suited for oral medication such as suckable tablets,
- PEARLITOL® SD and DC mannitol, a comprehensive range of granulated mannitol, with particular use in challenging or unstable formulations and appropriate for all types of tablets including chewable / oral dispersible or effervescent tablets.
Fillers - Diluents - Binders for Wet granulation
Wet granulation, a traditional manufacturing process, is still widely used. It is often required when the pharmaceutical form contains a high level of active ingredients.
Granules obtained by wet granulation are characterized by an uniform particle size distribution with few fine particles allowing an uniform filling of capsules, sachets or compression matrices, and giving very good compression profiles while maintaining low tablet disintegration time.
Diluents
Diluents are inert powders acting as fillers in the formulation of tablets, capsules and powders for sachets. Roquette offers a range of both water-soluble or water-insoluble diluents that also have a disintegration function:
The starches or partially pregelatinized starches are traditional excipients, among the most used and trusted insoluble excipients in the world, having the added function of disintegration aid:
The large range of soluble diluents include maltodextrins, dried glucose syrups, dextrose -monohydrate and anhydrous-, and the highly functional polyols appreciated for their physicochemical stability, organoleptic properties (sweetening power, cooling effect) and sugar-free, dietary benefits:
Binders
Wet granulation can be achieved through different processes, the wetting and granulation having a marked impact on the quality of the final granules. Roquette has specifically developed pharmaceutical binders with different degrees of water solubility or dispersibility:
- LYCATAB® PGS, a pregelatinized dispersible starch, ideally used in dry blends
- LYCATAB® DSH, a water-soluble maltodextrin binder suitable for preparation of granulation solutions or use in dry blends.
Disintegrants and Superdisintegrants
Disintegrants and superdisintegrants are used in tablets and capsules to ensure that these compacts are rapidly broken down into the primary particles to facilitate the dissolution or release of the active ingredients.
ROQUETTE has developed a versatile range of standard disintegration excipients ranging from the traditional native starches to the innovative multifunctional starch compound StarLac®, and the partially pregelatinized starch LYCATAB® C, and has extended its offer of superdisintegrant, GLYCOLYS® sodium starch glycolate, with three unique grades of this market reference product to meet specific formulation needs:
- GLYCOLYS®
- GLYCOLYS® LV
- GLYCOLYS® Low PH
Excipients for molecular encapsulation
The formation of molecular inclusion complexes with cyclodextrins has become an accepted formulation strategy to improve the solubility or stability of active ingredients and can also be used to improve the taste of bitter or unpleasant drugs.
Roquette has pioneered the development of betacyclodextrin technology leading to a full range of KLEPTOSE® betacyclodextrins, with different powder properties, chemical substitution or solubility profile to suit modern formulation needs:
* under development
Encapsulation for coating
Excipients for film coating
Film coating is widely used by the Pharmaceutical industry for aesthetic or functional purposes. Film coating is mainly used to mask unpleasant odours and tastes or to protect drugs from environmental factors.
Roquette's LYCOAT® modified starch is a film forming polymer, specifically developed for aqueous film coating for immediate release, that allows a quicker quality coating of tablets.
Ready-to-use solutions are also developed in partnership with Biogrund.
Excipients for hard coating
Hard Coating is the traditional method of covering tablets. It is mainly used to mask unpleasant odours and tastes or to protect actives against light.
Roquette‘s MALTISORB® maltitol powder has become the reference standard for sugar-free hard coating around the world. MALTISORB® maltitol successfully replaces sugar, and allows to achieving faster coating time while offering dietary benefits: sugar-free, low-caloric, non-cariogenic and suitable for diabetics.
Carrier for spray-drying or freeze-drying
Freeze-dried products exhibit porous and brittle structures that are highly water sensitive.
The chemical nature of PEARLITOL® mannitol (crystalline, granulated), as well as its remarkable non-hygroscopic crystalline structure, makes it the excipient of choice for freeze drying formulation.
Excipients for liquid forms
Syrups, Solutions, Liquid ampoules, Dispersions, Semi-solids, Softgels
Sweeteners
Polyols are sugarless bulk sweeteners that can be used as total substitutes for sucrose and meet organoleptic (sweetening power) and dietetic requirements (sugar-free, low-calorie, do not induce dental caries, may be advised for diabetics).
Roquette’s range of liquid polyols include the most wide-ranging NEOSORB® liquid sorbitol solutions and LYCASIN® and MALTISORB® liquid maltitol solutions with varying sweetness and viscosity profiles.
Roquette also proposes conventional glucose syrups sweeteners for liquid forms.
Anti-oxidants
In liquid preparations oxidation might result in the development of undesirable flavors and discoloration. The addition of a water-soluble anti-oxidant such as Roquette’s Sodium Erythorbate avoids these side reactions.
Sodium Erythorbate has the same anti-oxidant properties as sodium ascorbate but has no vitamin activity.
Buffering
Buffers are used to stabilize the pH of liquid formulations. Roquette has developed a range of natural, physiological buffering agents based on gluconic acid (lactone), sodium gluconate, and sodium lactate.
Encapsulation
The formation of molecular inclusion complexes with cyclodextrins has become an accepted formulation strategy to improve the solubility or stability of active ingredients and can also be used to improve the taste of bitter or unpleasant drugs.
ROQUETTE has pioneered the development of betacyclodextrin technology leading to a full range of KLEPTOSE® betacyclodextrins, with different powder properties, chemical substitution or solubility profile to suit modern formulation needs:
* under development
Paste products
Toothpastes, Mouthwashes, Dentifrices
Humectants
NEOSORB® liquid sorbitol is a range of special Roquette formulated sorbitol solutions which have become an industry reference for the formulation of all types of toothpastes as well as mouthwashes.
NEOSORB® liquid sorbitol is a safe, cost effective humectant, with a great sugar-free sweet and pleasant taste.
With a constant focus on innovation, Roquette has developed a new high purity liquid sorbitol, NEOSORB® 70/70 SB, with improved stability, making it the most suitable excipient for sensitive formulations. This patented grade is particularly suited for toothpaste containing alkaline ingredients.
Excipients for pharmaceutical confectionery
Lozenges, Pastilles, Chewing gum
Sweeteners
Sugar-free pharmaceutical confectionery is increasingly popular, in particularly for Over The Counter (OTC) medication, because it associates a convenient administration form and pleasant sweet taste with numerous dietetic requirements such as sugar-free, low calorie, dental safety and diabetic friendly formulations.
Roquette’s has developed a large collection of polyol based formulations for medicated lozenges, pastilles, chewing gum and other forms, depending on the desired sweetness, texture and other organoleptic criteria. Our team of development and regulatory specialists has helped in making such innovative administration forms an industrial and market reality.
Roquette also proposes conventional sweeteners with a wide range of glucose syrups for pharmaceutical confectionery formulations.
Injectable solutions, dialysis solutions, parenteral nutrition
Pyrogen free nutrients and osmotic agents
Injectable and dialysis solutions are critical preparations requiring high purity and reliable raw materials. Roquette is a leading world wide supplier of pyrogen free nutrients and osmotic agents such as:
These Roquette pyrogen free raw materials comply with the world’s most stringent pharmacopoeia specifications with comprehensive quality checking, purity and filterability taking place to ensure the high standards required for dialysis and infusion therapies.
Pyrogen free organic buffers
With the same quality approach, Roquette has further expanded its range of pyrogen free ingredients with the development of highly purified organic salts used as physiological buffers in the preparation of dialysis and injectable solutions:
Encapsulation
ROQUETTE has pioneered the development of betacyclodextrin technology leading to a full range of KLEPTOSE® betacyclodextrins. An alternative cyclodextrin derivative is suitable for parenteral solutions:
* under development
Ingredients for clinical nutrition and nutraceuticals
Nutrients, fibers, minerals (Calcium) and texture aids
Roquette offers a large range of starches and starch-based ingredients for the formulation of medicated or specialized nutrition such as infant and enteral nutrition with new products providing easy to use fiber and calcium supplementation.
These products provide the high level of nutritional quality which is absolutely required for these specialized nutrition applications:
- GLUCIDEX® maltodextrins and dried glucose syrups as energetic nutrients, in particular highly demineralised, are easily digested and well tolerated.
- CLEARAM®, CLEARGUM® and dextrins: modified starches, acting as viscosifiers for enteral preparations.
- NUTRIOSE® soluble fiber, valued for its outstanding digestive tolerance
- LYCATAB® Mineral: great tasting calcium source for tablets, capsules and sachets
