Pharma Ingredients & Services. Kolliphor EL. Macrogolglycerol Ricinoleate Ph. Eur., Poly oxyl 35 Cas tor Oil USP. Technical Information

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1 Technical Information March 2012 Supersedes issue dated December _111139e-02/Page 1 of 6 WF-No Kolliphor EL Macrogolglycerol Ricinoleate Ph. Eur., Poly oxyl 35 Cas tor Oil USP = Trademark of BASF group (former Tradename Cremphor EL) Solu bi liser and emul si fy ing agent for the human and vet e ri nary phar ma ceu ti cal indus tries; used in aque ous prep ar a tions of hydro pho bic API s. Pharma Ingredients & Services

2 03_111139e-02 March 2012 Page 2 of 6 Regulatory status Meets currrent Macrogolglycerol Ricinoleate Ph. Eur. and Poly oxyl 35 Cas tor Oil USP monographs. Chem i cal nature is a non ionic solu bi liser and emul si fier made by react ing cas tor oil with eth y lene oxide in a molar ratio of 1 : 35. Com po si tion The main com po nent of is glyce rol poly eth y lene gly col ricin o leate. Together with fatty acid esters of poly eth y lene gly col, this forms the hydro pho bic part of the prod uct. The smaller hydro phylic part con sists of free poly eth y lene gly cols and ethox y lated glyce rol. Descrip tion is a pale yel low oily liq uid that is clear at tem per a tures above 26 C. It has a faint but char ac ter is tic odour. The hydro philic-lip o philic bal ance (HLB) lies between 12 and 14. The crit i cal micelle con cen tra tion (CMC) lies at approx. 0.02%. Sol u bil ity forms clear solu tions in water. It is also sol u ble in many organic sol vents, e.g. ethyl alco hol, n-pro pyl alco hol, iso propyl alco hol, ethyl ace tate, chlo ro form, car bon tet ra chlo ride, tri chlo ro eth y lene, toluene and xylene. In con trast to anionic emul si fy ing agents, becomes less sol u ble in water at higher tem per a tures. Thus, aque ous solu tions become tur bid at a cer tain tem per a ture. is mis cible with all the other Kolliphor grades and, on heat ing, also with fatty acids, fatty alco hols and cer tain ani mal and veg e ta ble oils. It is thus mis cible with oleic and stearic acids, dode cyl and octa -d e cyl alco hols, cas tor oil, and a num ber of lipid-sol u ble sub stances. Specification See separate document: Standard Specification (not for regulatory purposes) available via BASF s WorldAccount: (registered access). Stabil ity is stable for at least 2 years if stored in the unopened orig i nal con tain ers at room tem per a ture (max. 25 C). In aque ous solu tions, is stable towards elec tro lytes, e. g. acids and salts, pro vided that their con cen tra tion is not too high. Mer cury(ii) chlo ride is an excep tion, as it forms a pre cip i tate with the prod uct. Sim i larly, some organic sub stances may cause pre cip i ta tion at cer tain con cen tra tions, espe cially com pounds con tain ing phe nolic hydroxyl groups, e.g. phe nol, resor ci nol and tan nin. can be ster il ized by heat ing in an auto clave for 30 min utes at 120 C. This may give it a deeper shade. To avoid sapon ifi ca tion, should not be heated together with very acidic or basic sub stances. Appli ca tions is rec om mended as a solu bi lizer and emul si fier in many dif fer ent branches of indus try. It is par tic u larly suit able for the pro duc tion of liq uid prep ar a tions. The form in which a hydro pho bic sub stance is dis trib uted in a liq uid depends largely on its prop er ties and on the amount of used. It has been found that, as a rule, if is present in excess, clear or opal es cent liq uids are obtained. How ever, if the pro por tion of is reduced to 5 10% of the water-insol u ble sub stance, con di tions exist for the for ma tion of an emul sion.

3 03_111139e-02 March 2012 Page 3 of 6 Phar ma ceu ti cal prep ar a tions emul si fies or sol u bi lizes the fat-sol u ble vita mins A, D, E and K in aque ous solu tions for oral and top i cal admin is tra tion. In aque ous-alco holic solu tions, it very read ily sol u bi lizes essen tial oils. Aque ous solu tions of hydropho bic drugs (e. g. Micon a zole, Hex ed e tine, Clo trim a zole, Ben zo caine) can also be pre pared with. To ensure that the fat-sol u ble vita mins yield clear aque ous solu tions, they must first be inti mately mixed with the solu bi lizer. The pre ferred forms of vita min A for this pur pose are Vita min A Pal mi tate 1,700,000 I.U./g or Vita min A Pro pion ate 2,500,000 I.U./g; the pre ferred form of vita min K is the K1 form (phy tom e nad i one). As the method used to solu bil ise a sub stance plays an impor tant role, a typ i cal exam ple, the prep ar a tion of an aque ous vita min A pal mi tate solu tion is described in detail below. Vita min A Pal mi tate 1,700,000 I. U./g Water 8.8 g 25.0 g ad 100 ml The vita min is mixed with the, heated to C and incor po rated into the water also heated to C. Initially, thick en ing occurs as a result of hydra tion, which reaches a max i mum when about half of the water has been added. On addi tion of the remain ing water, the vis cos ity decreases again. If the first half of the water is added too rap idly, a tur bid solu tion may be obtained. The fol low ing three dia grams show that clear aque ous solu tions with very high con cen tra tions of vita min A pal mi tate, vita min A pro pion ate or vita min E ace tate can be obtained with the aid of. The con cen tra tions refer to the fin ished sol u bil i sates. Fig. 1 Vita min A pal mi tate

4 03_111139e-02 March 2012 Page 4 of 6 Fig. 2 Vita min A pro pion ate Fig. 3 Vita min E ace tate

5 03_111139e-02 March 2012 Page 5 of 6 The fol low ing amounts of other fat-sol u ble vita mins can be dis solved in a 6% solu tion of : approx. 200,000 I.U. vita min D 3 /ml or approx. 10 mg vita min K 1 /ml As a rule, less is required for mix tures of dif fer ent vita mins. Vita min A + vita min D 3 + vita min con cen trate, water-mis cible (120,000 I. U. + 60,000 I. U mg/l) 1. For mu la tions I. Vita min A Pal mi tate 1,700,000 I. U./g 7.10 g Vita min A Pro pion ate 2,500,000 I. U./g 4.80 g Vita min D3 40,000,000 I. U./g 0.15 g 0.15 g Vita min E Ace tate 4.20 g 4.20 g Butylhydrox y to luene 0.06 g 0.06 g 30.0 g 30.0 g II. Gly ce rin 6.50 g 6.50 g Pre ser va tive q. s. q. s. Water ad 100 ml ad 100 ml 2. Pro ce dure Heat Mix tures I and II to about 65 C and slowly incor po rate Mix ture II into Mix ture I with stir ring. 3. Prop er ties of the solu tion Clear yel low vis cous liq uid that is mis cible with water. Clar ity: For mu la tion No. 1: 28 FTU For mu la tion No. 2: 32 FTU Vita min E solu tion with eth a nol (0.01% = 1 mg/10 ml) 1. For mu la tion I. Vita min E Ace tate 10 mg g II. Water 57.0 g Eth a nol 38.0 g 2. Pro ce dure Heat Mix ture I to about 60 C and slowly incor po rate the warm sol vent mix ture II with stir ring. 3. Prop er ties of the solu tion Clear colour less liq uid of low vis cos ity. The pro cess ing tem per a ture and, in some cases, the amount of required can be reduced by add ing small amounts of poly eth y lene gly col ( Lutrol E 400), pro py lene gly col or glyce rol. The stabil ity of many sol u bil i sates may be affected by light. For oral dos age forms in human med i cine, it is rec om mended to use the hydrogen ated form, Kolliphor RH 40 which is taste less. The char ac ter is tic taste of can usu ally be masked best with banana aroma. A solu tion of one part of azu lene in about four parts of is freely mis cible with water. In addi tion, has proved to be a use ful addi tive in the pro duc tion of glyce rol sup pos i to ries. Tox i col ogy After having signed a secery agreement, reports of the tox i co log i cal stud ies are avail able on request.

6 03_111139e-02 March 2012 Page 6 of 6 Impor tant note The fine dis per sion of com pounds that can be achieved with the aid of Kolliphor EL improves their absorp tion char ac ter is tics and effi cacy. pro motes the pen e tra tion of a num ber of active sub stances and can exert either acti vat ing or inac ti vat ing effects on oth ers, e. g. anti bi o tics. There fore, before prep ar a tions are used in prac tice, it is advis able to sub ject them to thorough phar mac o log i cal tests. is sub jected to thorough qual ity con trols involv ing com pre hen sive chem i cal and phys i cal tests. The indi vid ual pro duc tion batches are not, how ever, sub jected to bio log i cal tests. For this rea son, pro duc ers of prep ar a tions that con tain must carry out their own tests to check the suit abil ity of the respec tive mate rial and of the final prep ar a tions. Cat tle that have been given cer tain vac cines or medic a ments paren ter ally and have sub se quently been injected with prep ar a tions con tain ing or sim i lar sol u bi liz ers have dis played anaph y lac tic reac tions in iso lated cases involv ing excep tional cir cum stances. Anaph y lac tic reac tions have occa sion ally been observed in humans after injec tions con tain ing. For this rea son, the health author ities in the Fed eral Repub lic of Ger many and the UK, for instance, have laid down that the con tent of poly ethox y lated cas tor oil in injec tions for paren teral admin is tra-tion to humans must be declared, and that atten tion must be drawn to the pos sibil ity of side effects in the pack age insert. This is an aspect to which companies pro duc ing phar ma ceu ti cals for human use must pay par tic u lar atten tion. No side effects of this kind have been observed after oral admin is tra tion of pre p ar a tions con tain ing. Recommendations for product handling and sampling For proper product handling and sampling homogenization of the drum content is necessary. The new drums allow the repeated liquefaction of their content at around 60 C. It is recommended to use electrical drum heaters, heating covers or a heating chamber. PRD-No Pack ag ing 60 kg and 120 kg remov able-head steel drums with a Lupo len inliner with its own lid. Stor age should be stored in tightly closed con tain ers pro tected from light. Pro longed stor age is not rec om mended unless the con tain ers are com pletely full. Safety Data Sheet A Safety Data Sheet is avail able for. Note This document, or any answers or information provided herein by BASF, does not constitute a legally binding obligation of BASF. While the descriptions, designs, data and information contained herein are presented in good faith and believed to be accurate, it is provided for your guidance only. Because many factors may affect processing or application/use, we recommend that you make tests to determine the suitability of a product for your particular purpose prior to use. It does not relieve our customers from the obligation to perform a full inspection of the products upon delivery or any other obligation. NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS DESCRIBED OR DESIGNS, DATA OR INFORMATION SET FORTH, OR THAT THE PRODUCTS, DESIGNS, DATA OR INFORMATION MAY BE USED WITHOUT INFRINGING THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS. IN NO CASE SHALL THE DESCRIPTIONS, INFORMATION, DATA OR DESIGNS PROVIDED BE CONSIDERED A PART OF OUR TERMS AND CONDITIONS OF SALE. March 2012 BASF SE - Nutrition & Health - Pharma Ingredients & Services Lampertheim -

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