`
`The 3 in 1 Polymer for
`pharmacy
`
` SEPINEO™ P 600
`Description
`
`SEPINEO™ P 600 belongs to the SEPINEO™ new range
`specifically dedicated to your topical drug developments.
`
` SEPINEO™ P 600:
`Thickening power
`
` SEPINEO™ P 600:
`Emulsifying power
`
` SEPINEO™ P 600:
`Stabilizing power
`
` SEPINEO™ P 600:
`Formulation advices
`
`SEPINEO P 600 description
`The thickening- emulsifying polymer for topical applications.
`
`SEPINEO™ P 600, HSD polymer
`“““HHHYYYDDDRRROOO SSSWWWEEELLLLLLIIINNNGGG DDDRRROOOPPPLLLEEETTTSSS”””
`
`In presence of water, SEPINEO™ P 600 reverses and the polymer
`network deploys instantly, forming a perfectly stable gel in a few
`seconds.
`
`SEPINEO™ P 600 benefits:
`
`Ready to use fluid form
`Very easy to handle at room temperature: No neutralisation,
`No rehydratation.
`Thickens over a large pH range : pH 2 to 12
`Stabilizes and thickens O/W emulsions
`Gel-Cream texture: Emulsifies all oily phases at Room
`temperature
`Good skin tolerance
`Regulatory status: US-DMF n° 21266
`
`Already used in a drug with NDA (New Drug Application)
`
`SEPINEO P 600: thickening power
`The SEPINEO™ P 600 thickens water from low concentrations.
`Increase of viscosity as a function of polymer concentration is
`linear and SEPINEO™ P 600 is effective over a very wide pH range.
`SEPINEO™ P 600 is able to thicken solvent-rich media such as
`ethanol, acetone, glycerin, glycols...Thus, it enables to formulate
`water
`sensible
`actives
`in
`anhydrous
`formulations.
`
`1
`
`AMN1026
`
`Mylan (IPR2019-01095) MYLAN1026, p. 001
`
`
`
`SEPINEO P 600: Emulsifying power
`SEPINEO™ P 600, an Hydro Swelling Droplet (HSD) polymer in an invert emulsion, is able to emulsify
`and stabilize many oily phases.
`
`WITHOUT addition of a conventional emulsifier
`WITHOUT HLB calculation
`WITHOUT neutralization (pre-neutralized polymers)
`
`Different oily phases can be emulsified successfully, whatever their nature: polar and non
`polar oils, vegetable oils, silicone oils, esters.
`
`The gel-creams obtained are stable and have a perfectly uniform appearance. The “gel-
`cream” concept is a novel product form, very pleasant for the touch and spread on the skin.
`
`SEPINEO™ P 600 : Emulsion stabilizing power
`In addition to these thickening/emulsifying properties, SEPINEO™ P 600 stabilizes
`conventional emulsions. In such cases, the SEPINEO™ P 600 concentration can be lower, from
`0.5% to 2.0%, and must be determined according to the nature of the other ingredients of
`the formula.
`
`SEPINEO™ P 600 : formulation advices
`In emulsion: SEPINEO™ P 600 performs well when added at the end of high temperature
`emulsification ( 70-75 °C). It can also be added at the beginning of the process in the oil or
`aqueous phase as it is perfectly stable at high temperatures.
`
`In gel-cream: SEPINEO™ P 600 can be introduced either in the oily phase or in the aqueous
`phase: its performance in terms of texture and stability is similar whatever the process.
`However, the stirring step needs less energy when SEPINEO™ P 600 is introduced in the oily
`phase.
`In hydroglycolic/ hydroalcoholic/ acetone gel: It is advisable to prepare the aqueous gel first
`and then add the solvent gradually, while stirring.
`
`SEPINEO™ P 600 doses of use
`gel application => thickening power: up to 5%
`cream application => stabilizing power: 0,5% to 2%
`Gel-Cream => emulsifying power: up to 5%
`
`-
`-
`-
`
`Nota
`The analytical specifications warranted are only those mentioned on the certificate of analysis supplied with each delivery of the product.
`Except as set forth above, SEPPIC* makes no warranties, whether express, implied or statutory, as to the product which is the subject of this
`document . Without limiting the generality of the foregoing, SEPPIC* makes no warranty of merchantability of the product or of the fitness of the
`product for any particular purpose. Buyer assumes all risk and liability resulting from the use or sale of the product, whether singly or in combination
`with other goods. The information set forth herein is furnished free of charge and is based on technical data that SEPPIC* believes to be reliable. It is
`intended for use by persons having technical skill and at their own discretion and risk. Since conditions of use are outside SEPPIC*'s control, SEPPIC*
`makes no warranties, express or implied, and assumes no liability in connection with any use of this information. Nothing herein is to be taken as a
`license to operate under or a recommendation to infringe any patents.
`* SEPPIC being:
`Tel. : +33 (0)1 42 91 40 00
`Fax : +33 (0)1 42 91 41 41
`SEPPIC S.A.
`
`and, depending on the country :
`
`SEPPIC UK Ltd
`Tel.: +44 208 577 8800
`
`SEPPIC Inc.
`Tel.: +1 973 882 5597
`
`SEPPIC Italia Srl
`Tel. : +39 02 38009110
`
`SEPPIC Brasil
`Tel. : +55 11 3242 3911
`
`SEPPIC Asia Singapore
`Tel. : +65 6278 6711
`
`SEPPIC Colombia SAS
`Tel. : +571 702 44 48
`
`HEAD OFFICE
`75, quai d’Orsay
`75007 Paris/ FRANCE
`
`SEPPIC S.A. France
`Tel. : +33 (0)1 42 91 40 00
`
`SEPPIC Japan Office
`Tel : +81 3 6414 6725
`
`SEPPIC Dubai Offic
`Tel : +971 (4) 2395565
`
`SEPPIC Mumbai
`Tel : +91 22 42726464
`
`SEPPIC Gmbh
`Tel.: +49 (0) 2203-89830-20
`
`SEPPIC China
`Tel. : +86 (21) 64 66 01 49
`
`3664/GB/02/April 2008
`
`2
`
`Mylan (IPR2019-01095) MYLAN1026, p. 002
`
`