Products & Services. HARKE Pharma GmbH. Xantener Straße Mülheim an der Ruhr Germany

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1 Products & Services 09/13Pharma HARKE Pharma GmbH Xantener Straße Mülheim an der Ruhr Germany Phone +49 (0) Fax +49 (0) pharma@harke.com Internet Follow us on Twitter or Facebook

2 Overview HARKE Pharma Introduction 4 Our Services 6 The clear way to successful formulations: HARKE Pharma Our Competences 10 Technologies and Products 10 Coating 12 Sustained Release 14 Tabletting 16 Granulation/Pelletization 18 Patch Systems/Ophthalmology 19 Solubility 20 Scientific Services 21 Capsules 22 Gels and Liquids 23 Guide to Application 24 Quick References 26 Regulatory Status 26 Our Partners 28 A Z 30

3 Introduction 30 Years of Innovation Jahre Innovation Von Mülheim aus in die Welt der pharmazeutischen Technologie HARKE Pharma 30 years of innovation From Mülheim to the world of pharmaceutical technology HARKE Pharma Ob Tabletten, Pellets, Kapseln oder Salben HARKE Pharma ist Ihr Ansprechpartner für pharmazeutische Hilfsstoffe und galenische Problemstellungen: Von der chemischen und physikalischen Stabilität über die Wirkstoffverteilung bis hin zur äußeren Form des Arzneimittels. Wir sind Ihr professioneller Ansprechpartner bei der Realisierung Ihrer Produktidee. Tablets, pellets, capsules or ointments HARKE Pharma is your partner for pharmaceutical excipients and galenical developments. When it comes to chemical and physical drug stability, drug targeting or dosage form appearance, we are your professional partner for the realization of your ideas for products. HARKE Pharma steht für mehr als 30 Jahre Erfahrung in der pharmazeutischen Technologie und bietet Ihnen nicht nur innovative Produkte namhafter Lieferanten, sondern berät und begleitet Sie bei der Formulierung neuer Arzneimittel. Unser Technologie- Team versorgt Sie mit detaillierten Informationen zu unseren Produkten und den neuesten Entwicklungen der Pharma-Branche. HARKE Pharma stands for 30 years of experience in pharmaceutical technology. Not only do we offer innovative products of world-class suppliers, but we also assist you concerning the formulation of new drugs. Our technology team provides you with detailed product information and keeps you informed about the latest trends and innovations. Der Know-how-Transfer ist für uns von größter Bedeutung, so kooperieren wir mit namhaften Universitäten und Instituten, organisieren Seminare, unterstützen Kongresse und stehen Ihnen mit unserem internationalen Netzwerk in ganz Europa zur Verfügung. Know-how transfer is of utmost importance for us this is why we co-operate with famous universities and institutes, organize seminars, sponsor congresses and are at your disposal with our international network throughout Europe. Thorsten Harke Geschäftsführender Gesellschafter President Dr. Jörg Brunemann Geschäftsführer Managing Director

4 Our Services Your Benefits: Our Servi ces 6 7 Customized Solutions Seminars, Congresses, Exhibitions Wir begleiten Ihre Projekte von der Idee bis zur Implementierung durch volle Unterstützung der Forschung und Entwicklung, Bereitstellung von wissenschaftlichen Hintergrundinformationen und kundenindividuellen Spezifikationen sowie durch verfahrenstechnische Beratung beim Scale-Up. We assist with your projects from idea to implementation - by full - yet modular - R&D support, supply of scientific back-up data, tailored specifications and procedural advice with scale-up. Wir veranstalten zahlreiche Seminare und praktische Workshops für unsere Kunden und Lieferanten zum Transfer von Know-how und beteiligen uns an wissenschaftlichen Kongressen, wie CRS und APV. We organize seminars and practical workshops for our customers and suppliers to transfer know-how and participate in scientific congresses, such as CRS and APV. Scientific Collaboration Technical Support Um unser wissenschaftliches Know-how und Prozessverständnis zu erweitern und zu vertiefen, kooperieren wir mit Forschungsgruppen an namhaften Universitäten und Forschungseinrichtungen. In order to expand and constantly improve our scientific know-how and process understanding, we co-operate with research groups of wellknown universities and research institutions. Mit prozesstechnischen Hilfestellungen und Anwendungsberatung stehen Ihnen unsere erfahrenen Technologen zur Seite, wann immer sie gebraucht werden. Our experienced technologists are at your disposal for procedural and implementation advice at any time.

5 Our Services Your Benefits: Our Servi ces 8 9 Europe-wide Assistance Synergies with other HARKE Group Business Units Wir unterhalten Büros in vielen Städten Europas. Unsere Experten stehen Ihnen damit zur Verfügung, wo immer sie gebraucht werden. We have offices in several European cities, thus enabling our experts to advise you anywhere, anytime. Health & Functional Food In diesem Bereich sind wir mit einer Vielzahl innovativer Darreichungsformen vertreten. Profitieren Sie von unserer Erfahrung in der Entwicklung und Fertigung neuartiger Produkte. In this field we are active with many innovative dosage forms. Profit from our experience in developing and manufacturing novel products. Food Technology Supply-Chain-Management Unsere Teams verstehen sich hinsichtlich des Supply - Chain-Managements als Teil Ihrer Wertschöpfungskette. Unser hochmodernes Warenwirtschaftssystem auf Basis SAP/R3 garantiert Chargen-Rückverfolgbarkeit sowie optimierte, bedarfsorientierte Planungsprozesse innerhalb der Lieferkette. Kommunikationswege transparent gestalten, Kosten minimieren und den Kundennutzen steigern das sind unsere Beiträge zu Ihrem Erfolg. Regarding your supply-chain-management, our teams consider themselves part of your value-chain. Our enterprise resource planning system (ERP) based on SAP/R3 guarantees batch traceability, as well as optimized planning adapted to your demand within your supply-chain. Allowing transparent communication, minimizing costs and enhancing the customer benefit - that s our contribution to your success. Viele Hilfsstoffe aus der pharmazeutischen Industrie finden auch in der Lebensmittelindustrie Verwendung. Profitieren Sie von unserem Know-how über deren Funktionalität in verschiedenen Anwendungen unter unterschiedlichsten Bedingungen. Many excipients are used both in the pharmaceutical and the food industry. Profit from our know-how about their function and application under various conditions. Cosmetics Auch hier finden eine Reihe von ähnlichen Hilfs- und Wirkstoffen sowie Technologien Anwendung. Profitieren Sie von unseren Kenntnissen über halbfeste Formen wie Cremes und Lotionen, die auch in der Pharmazie genutzt werden. The pharmaceutical and the cosmetic industry share common active substances, excipients and application technologies. Profit from our expertise on semi-solid forms like cremes and ointments, which are also used in the galenic science.

6 Our Competences Technologies and Produ cts Gels and Liquids Scientific Services Capsules Sustained Release Solubility Tabletting Coating Ophthalmology Granulation Pelletization Patch Systems

7 Our Competences Coating Gastrosoluble Coating Substitution Viscosity Type [USP] [mpas] Solvent Suitability Remarks Hypromellose, HPMC Pharmacoat aqueous/hydro-alcoholic small tablets, pellets, granules low pigment tolerance Pharmacoat ,5 aqueous/hydro-alcoholic Pharmacoat aqueous/hydro-alcoholic tablets Pharmacoat aqueous/hydro-alcoholic oblong tablets, logo tablets highest elasticity SB-4 (Hypromellose) aqueous/hydro-alcoholic Methyl Cellulose, MC Metolose SM-4 4 aqueous pellets, granules lower elasticity Metolose SM aqueous pellets, granules low stickiness Polyvinyl Alcohol, PVA Gohsenol EG-05PW - 5 aqueous tablets fast processing, high humidity protection Premixes Easpray TM GAI hydroalcoholic tablets based on HPMC Easpray TM GMI aqueous tablets based on PVA Easpray TM GAII alcoholic tablets based on HPMC/EC Coating Wir bieten eine Reihe innovativer Filmbildner, um feste Arzneiformen vor Feuchte, Abrieb oder der Säure des Magensaftes zu schützen und um Sicherheit, Compliance und den Marktwert Ihres Produktes zu erhöhen. To protect solid dosage forms against moisture, abrasion or gastric fluid, we offer several, highly-innovative coating polymers. Our excipients contribute to higher safety, patient compliance and increase your product value on competitive markets. Enteric Coating Solubility Solvent [ph] Remarks Hypromellose-Esters AQOAT LF aqueous 5,5 particle size 5 µm AQOAT MF aqueous 6,0 particle size 5 µm AQOAT HF aqueous 6,5 particle size 5 µm AQOAT LG organic 5,5 particle size 1000 µm AQOAT MG organic 6,0 particle size 1000 µm AQOAT HG organic 6,5 particle size 1000 µm HP-50 organic 5,0 particle size 1000 µm HP-55 organic 5,5 particle size 1000 µm HP-55S organic 5,5 enhanced tensile strength Sustained Release Coating Ethyl Cellulose, EC Grade ,5% - 49,5% Ethoxyl Content mpas Shellac SSB 55 alcoholic SSB 56 alcoholic SSB 57 alcoholic Aquagold aqueous 7,3 ±0,3 blending with HPMC shifts ph-solubility Premixes Eastrol TM RS Preformulated EC for aqueous processing Premixes Eascol TM EABL55 aqueous 5,5 polyacrylate-based Eascol TM EOBS68 hydroalcoholic 6,8 polyacrylate-based

8 Our Competences Sustained Release Sustained Release Hydrophile Matrizes auf Basis hochviskoser Hypromellose ermöglichen eine einfache und stabile Formulierung zur kontrollierten oder verzögerten Wirkstofffreisetzung. Hydrophilic matrices based on highly-viscous hypromellose allow for an easy and stable way to a controlled or sustained release of your active ingredient. High-viscous Hypromellose (HPMC) Viscosity [mpas] EP, USP MeO [%] HPO [%] Mean Particle Size [µm] D 60 [µm] Polyethylene Oxide (PEO) Grade Molecular 1 %-Viscosity 5 %-Viscosity Weight Range Range [Da] [mpas] [mpas] approx. PEO-20NF PEO-18NF PEO-15NF PEO-1NF PEO-1LNF Polyethylenoxid, PEO, ist ein lineares, nichtionisches, wasserlösliches Homopolymer aus Ethylenoxid. PEO ist zum Aufbau hydrophiler, diffusionskontrollierender Matrices geeignet. Polyethylene Oxide, PEO, is a linear, non-ionic, water soluble homopolymer derived from ethylenoxide. It is suitable to built up high-viscous matrices to achieve diffusion controlled release kinetics. USP 2910 Metolose 60SH Metolose 60SH Metolose 60SH USP 2906 Metolose 65SH ,5 425 Metolose 65SH ,5 425 Metolose 65SH ,5 425 EuRelease Retardierte Darreichungsformen bieten viele pharmakologische Vorteile und sind sehr verbreitet. Ihre Entwicklung aber ist zeit- und kostenintensiv. EuRelease nutzt jahrzehntelanges Know-how im Bereich Retardierung, um die Wirkstofffreisetzung auf wenige, leicht kontrollierbare Parameter zu reduzieren: Einsatzmenge und Tablettengröße. USP 2208 Metolose 90SH-100SR ,5 10, Metolose 90SH Metolose 90SH-4000SR ,5 10, Metolose 90SH Metolose 90SH-15000SR ,5 10, Metolose 90SH Metolose 90SH SR ,5 10, SR-dosage forms offer high pharmacological benefits, consequently the technique is broadly applied. However, the development of such dosage forms are tedious and costly. EuRelease uses decades of know-how in the field to break down the release-control of active substances to only two parameters: amount of excipient and tablet size. EuRelease I for readily soluble API EuRelease II for less-soluble API

9 Our Competences Tabletting Tabletting Binding and Disintegration Low-Substituted Hydroxypropyl Cellulose Tabletten sind die meistverbreitete Darreichungsform mit einem hohen Innovationspotential. Zur Direktverpressung, dem einfachsten und preiswerten Herstellungsverfahren, bieten wir Hilfsstoffe zur Lösung von Stabilitätsproblemen oder zur Entwicklung von schnellzerfallenden Tabletten (ODT). Tablets are the most abundant dosage form and there is still a high potential for innovations. For direct compression, the easiest and most efficient manufacturing process, we offer excipients for enhanced stability or for the formulation of oral disintegrating tablets (ODT). Mean Bulk Tap Angle of Hydroxy- Characteristics Particle density density Aspect repose propoxyl Typical application L-HPC Size [µm] [g/ml] [g/ml] ratio [ ] [%] Direct compression LH-11 Highly fibrous 55 0,33 0,56 5, (anti-capping) Moderately Regular grade LH-21 fibrous 45 0,38 0,63 3, (dry mixing, wet granulation) Moderately Lower hydroxypropyl LH-22 fibrous / low DS 45 0,36 0,63 3, than LH-21 (sometimes better disintegration) Fluid-bed granulation, direct LH-B1 Non fibrous 55 0,48 0,69 2, compression for high-load formulations Uniform Regular grade (direct NBD-021 particle shape 45 0,32 0,51 2, compression, wet granulation) Uniform Quick disintegration, NBD-022 particle shape 45 0,32 0,51 2, orally disintegrating tablets Binder Medicated Chewing Gum Disintegrant Stability Improvement Metolose SM-4 Pharmacoat 603 Pharmacoat 606 Povidone K-25 Povidone K-30 Povidone K-90 MC HPMC HPMC PVP PVP PVP Health in Gum (HiG) PWD 01/02/03 easy way to medicated chewing gum by tabletting on standard equipment PVPP-CL (Crosslinked PVP) PVPP-XL-10 (Crosslinked PVP) Lubricants Sugar Esters Stearate / Behenate β-cyclodextrin Filler Dibasic Calcium Phosphate (anhydrous / dihydrate) Oral Disintegrating Tablets Tabletting of Oily Formulations & Flowability Improvement F-Melt Type C / Type M / Type F1 Fujicalin synthetic, highly-amorphous dicalcium phosphate Neusilin synthetic, highly-amorphous magnesium aluminometasilicate

10 Our Competences Granulation / Pelletization Patches / Ophthalmology Granulation / Pelletization Patch Systems Schlecht fließende Pulvermischungen in frei-fließen- Turning poorly flowing powders into free flowing Topische Systeme wie Wirkstoffpflaster gewinnen Topical systems such as patches are of gaining interest de Granulate umzusetzen, ist ein weit verbreiteter granules is a basic operation in the pharmaceutical an Bedeutung. Sowohl Hydroxypropylmethylcellulo- and importance. Hydroxypropyl Methyl Cellulose and Prozess in der pharmazeutischen Produktion. Für industry. We recommend robust starter cores made se als auch PVA können hier zum Einsatz kommen. PVA both may be applied for these techniques. Layering Prozesse empfehlen wir Ihnen robuste Star- of microcrytalline cellulose (Cellets ), for your laye- terkerne aus mikrokristalliner Cellulose (Cellets ). ring process. Feinkörnige L-HPC Typen eignen sich hervorragend zur Fine L-HPC grades are ideal for the preparation PVA Herstellung von Pellets durch Extrusion/Spheronisation. of pellets by extrusion/spheronization. EG 05 P EG 05 PW EG 18 P Binder Gohsenol EG 05 P PVA Neutral Pellets from Microcrystalline Cellulose Layering Fraction EG 30 P EG 30 PW Gohsenol EG 18 P PVA Cellets µm Metolose SM-4 MC Cellets µm Pharmacoat 603 HPMC Cellets µm Pharmacoat 606 HPMC Cellets µm Povidone K-25 Povidone K-30 PVP PVP Cellets µm Cellets µm Ophthalmic Applications Povidone K-90 PVP PVA kann in Augentropfen zur Befeuchtung des PVA can be applied to keep eyes moist. Optimized Binder / Disintegrant L-HPC LH-21 Hydroxypropyl Cellulose, low substituted, for Extrusion / Spheronization Auges eingesetzt werden. Optimale Lichtdurchlässigkeit und die Abwesenheit fibröser Partikel sind die entscheidungsrelevanten Kriterien. optical transmission and absence of residual fibres are the relevant deciding factors. L-HPC LH-22 L-HPC LH-B1 L-HPC LH-B1 L-HPC NBD-020 L-HPC NBD-020 PVA Gohsenol 30 P Gohsenol 40 P

11 Our Competences Solubility Scientific Services Solubility Bioavailability Geringe Löslichkeit in Wasser und in der Folge eine unzureichende Bioverfügbarkeit sind die Herausforderungen der modernen galenischen Forschung. Solid Dispersion, z. B. mit HPMC- Estern oder die Verwendung von Surfactants können Wege sein, die Löslichkeit zu verbessern. Low aqueous solubility and the resulting poor bioavailabilty of many new APIs are major challenges in modern galenics. Solid Dispersion, e.g. with HPMC-esters, or the use of surfactants may be options to enhance the solubility of drugs within your formulation. Wirkstoffe müssen biologische Membranbarrieren überwinden, um an ihren Rezeptor zu gelangen. Wir charakterisieren die apparente Permeabilität Ihrer Formulierung in verschiedenen Modellmembranen. Hilfsstoffe können bei der Resorption von Wirkstoffen helfen, z.b. in dem sie aktive Efflux-Mechanismen hemmen. Actives need to cross biological membrane barriers to reach their receptor. We characterize the apparent permeability of your formulation in different model membranes. Excipients may help to increase the resorption of drugs, e.g. by inhibiting active efflux mechanisms. Carriers for Solid Dispersion Surfactants Services Hydroxypropyl Methyl Cellulose Acetate Succinate HPMC-AS (AQOAT) LF aqueous ph 5,5 HPMC-AS (AQOAT) LG organic ph 5,5 HPMC-AS (AQOAT) MF aqueous ph 6,0 HPMC-AS (AQOAT) MG organic ph 6,0 HPMC-AS (AQOAT) HF aqueous ph 6,5 HPMC-AS (AQOAT) HG organic ph 6,5 Hydroxypropyl Methyl Cellulose Phthalate HPMC-P HP-50 ph 5,0 HPMC-P HP-55 ph 5,5 HPMC-P HP-55S ph 5,5 Sugar Ester Stearate Palmitate Laurate Oleate Behenate Chelating Agent β-cyclodextrin Pharmacokinetics; PK-ADME-Characterization of different routes of administration: Gastrointestinal, dermal, ocular, nasal, pulmonal, blood brain barrier.

12 Our Competences Capsules Gels and Liquids Gels and Liquids Gele, Pasten und Säfte sind Arzneiformen mit großer Verbreitung. Zur Verdickung bieten wir Methylcellulose sowie Na-Carboxymethyl-Cellulose. Zur Stabilisierung von Emulsionen stellen wir milde, geschmacksneutrale und proteinstabilisierende Surfactants in Form von Zuckerestern zur Verfügung. Gels, pastes and ointments are commonly used. We offer methylcellulose and sodium carboxymethylcellulose as thickeners. To stabilize emulsions we provide specialized and mild (tasteless and protein protecting) surfactants such as sugar esters. Capsules Neben Tabletten sind Hartkapseln aus Gelatine oder HPMC weit verbreitete Arzneiformen. Für unterschiedliche Projektansätze stehen eine Reihe von Kapsel-Typen zur Verfügung. Darüber hinaus kann eine große Vielfalt an Hartgelatine- und HPMC-Kapseln genutzt werden: - alle Farben nach Kundenwunsch, auch bestehende Kapseln exakt nachstellbar - variable Druckmöglichkeiten zum Markenschutz (bis zu vier Farben, unidirektional oder zirkular) Capsules made of gelatin or HPMC are frequently used solid dosage forms. For different projects capsules can be chosen from a wide range of types. In addition hard gelatin- and HPMC-capsules are available in many variations: - all colors possible according to customers needs; even existing capsules can be reproduced exactly - various printing possibilities for brand protection (up to four colors, unidirectional or circular) Thickening, Gel-Preparation Viscosity Viscosity 1% Solution 2% Solution Degree [mpas] [mpas] of Substitution Methyl Cellulose Metolose SM ,5 31,5 % Metolose SM ,5 31,5 % Metolose SM ,5 31,5 % Metolose SM ,5 31,5 % Metolose SM ,5 31,5 % Hypromellose, HPMC, USP 2910 [%] Metolose 60 SH Meo/7 12 HPO Na-Carboxy Methyl Cellulose PL ,70 0,80 PV ,85 0,95 PM 200B ,60 0,70 PH 1800B ,55 0,65 Brand Type Available Sizes EZEEFIT TM Hard gelatin capsules 000, 00, 0, 0el, 1, 2, 3, 4 (others on inquiry) NATURECAPS TM HPMC capsules 00, 0, 1, 2, 3, 4 (others on inquiry) FLOFIT TM Capsules for liquid filling 00, 0, 1, 2, 3, 4 (others on inquiry) CLINICAPS TM Capsules for double-blind studies AA, A, B MARINECAPS TM Fish gelatin capsules 00, 0, 1, 2, 3, 4 (others on inquiry) PEARLZ TM Capsules with shining finish 00, 0, 1, 2, 3, 4 (others on inquiry) Surfactants, Sugar Esters Percentage HLB of main Mono Higher fatty acid ester ester Sucrose Stearate 3 16 approx. 70 approx approx Sucrose Palmitate Sucrose Laurate

13 Our Competences Guide to Application Film Coating Enteric Coating Pellet Coating Barrier Coating Taste Masking Surface Improvement Binder Dry Binder Disintegrant Anti Capping Lubrication Roller Compaction Sustained Release ODT Formulations Direct Compression Drug Layering Pellet Extrusion Solid Dispersion Solubility Enhancement Water Adsorption Oil Adsorption Thickening Eye Drops Emulsifier Swelling Agent Capsule Making Dispersion Aid AQOAT Cellets Crosslinked PVP β-cyclodextrin Dibasic Calcium Phosphate Ethyl Cellulose HPMC-AS MCC-Pellets PVPP-CL β-cd DCP EC F-Melt Fujicalin Gohsenol Health in Gum HP DCPA PVA HiG HPMC-P L-HPC Metolose SH/SR Metolose SM HPMC MC Na-CMC Neusilin Pharmacoat Polyethylene Oxide Povidone MAS HPMC PEO PVP Premixes Shellac Sugar esters

14 Quick References Regulatory Status Products Regulatory Status CAS DMF E-Number FCC AQOAT HPMC-AS USP (NF), JPE Aquagold Aqueos Shellac Solution USP, EP, JP composite NO Cellets MCC-Pellets USP (NF), EP, JPE composite YES Crosslinked PVP PVPP-CL USP, EP YES β-cyclodextrin β-cd USP (NF), EP Dibasic Calcium Phosphate DCPA USP, EP (ii) YES Anhydrous Dibasic Calcium Phosphate DCP USP, EP (ii) YES Dihydrate Ethyl Cellulose EC USP, EP, JP F-Melt C USP (NF), EP, JP composite assigned NO F-Melt M USP (NF), JP composite --- NO Fujicalin DCPA USP (NF), EP, JP Gohsenol PVA USP, EP, JP HP HPMC-P USP (NF), EP, JP L-HPC HPC low substituted USP (NF), JP Metolose HPMC USP, EP, JP YES Metolose SM MC USP, EP, JP YES Metolose SR HPMC USP, EP, JP YES Neusilin MAS USP (NF), JP Pharmacoat HPMC USP, EP, JP YES Polyethylene Oxide PEO Povidone PVP USP, EP upon request SSB Pharma Grades Shellac Flakes USP, EP, JP NO Surfhope SE Pharma Sugar Ester depending on type * depending on type * depending on type * 473 * Please contact our technical sales team.

15 Quick References Our Partners ACG Worldwide, Mumbai, Indien ACG Worldwide zählt zu den weltweit größten Herstellern von Kapseln aus Gelatine und Cellulose, führend auch in der Befüllungstechnologie und beim grafischen Kapseldesign. ACG Worldwide, Mumbai, India ACG Worldwide is a leading supplier of hard capsules made of gelatin or HPMC. ACG not only produces capsules but is also leading the industry regarding filling, spin and axial imprinting. Across Barriers GmbH, Saarbrücken, Deutschland Dienstleistungsunternehmen für neue Technologien im Bereich Forschung und Entwicklung von Pharmaka. Across Barriers GmbH, Saarbrücken, Germany Service enterprise for drug delivery techniques. Cafosa Gum S.A.U., Barcelona, Spanien Tochterunternehmen der Mars & Wrigley Firmengruppe. Liefert "Health in Gum", eine Vormischung zur Darstellung medizinischer Kaugummis durch Direktverpressung. Cafosa Gum S.A.U., Barcelona, Spain Part of the Mars & Wrigley company. Supplies "Health in Gum", a direct compressible blend to prepare medicated chewing gums. EKA Chemicals AB, Bohus, Schweden Tochterunternehmen der AKZO Gruppe, führender europäischer Anbieter von Natriumhydroxid und Kaliumhydroxid in hochreiner Form. EKA Chemicals AB, Bohus, Sweden A subsidiary of the AKZO group. A leading European manufacturer of high purity sodium hydroxide and potassium hydroxide, suitable e. g. for parenteral applications. Fuji Chemical Industry Co., Ltd., Tokio, Japan Renommierter Hersteller pharmazeutischer Hilfsstoffe, unter anderem zur Entwicklung schnellzerfallender Tabletten. Fuji Chemical Industry Co., Ltd., Tokyo, Japan Reliable manufacturer of pharmaceutical excipients, e.g. for the development of fast disintegrating oral dosage forms. ILE Pharmaceutical Materials Co., Ltd., Tianjin, VR China ILE produziert die volle Bandbreite direkt einsetzbarer Filmbildner für die pharmazeutische Industrie. ILE Pharmaceutical Materials Co., Ltd., Tianjin, PR China ILE produces a full range of ready-to-use pharmaceutical coating solutions. IPC Process Center GmbH & Co. KG, Dresden, Deutschland Die IPC Process Center GmbH & Co. KG in Dresden ist eine Tochter der Glatt Systemtechnik GmbH und produziert wirkstofffreie Cellulose-Pellets. IPC Process Center GmbH & Co. KG, Dresden, Germany IPC Process Center GmbH in Dresden is an affiliate of Glatt Systemtechnik GmbH, producing non-pareils made from microcrystalline cellulose. Mitsubishi - Kagaku Foods Corporation, Tokio, Japan Tochtergesellschaft der Mitsubishi Chemical Corporation. Spezialisiert auf die Herstellung von Zuckerestern, einsetzbar als Emulgator oder Schmiermittel in der Lebensmittelindustrie und pharmazeutischen Industrie. Mitsubishi - Kagaku Foods Corporation, Tokyo, Japan Affiliate of Mitsubishi Chemical Corporation. Specialized in the production of sucrose esters, useful as emulsifier or lubricant in the food- and pharmaceutical industry. Nature Industries Limited, Nanjin, VR China Nature Industries ist unser regionaler Partner in der VR China zur Erschließung dieses Beschaffungsmarktes für unsere Kunden. Nature Industries Limited, Nanjin, PR China Nature Industries is our partner in the PR China to access this giant, upcoming sourcing market for our customers. Nippon Gohsei Co., Ltd., Osaka, Japan Nippon Gohsei produziert PVA/Polyvinylalkohol zur Befilmung fester Arzneiformen mit einer geringen Wasserdampfdurchlässigkeit. Nippon Gohsei Co., Ltd., Osaka, Japan Nippon Gohsei produces polyvinyl alcohol (PVA) for the coating of solid dosage forms with a superior moisture barrier function. Shin-Etsu Chemical Co., Ltd., Tokio, Japan Shin-Etsu ist der führende Hersteller von Cellulose-Ethern aus GMP-konformer Produktion für die pharmazeutische Industrie, die Lebensmittelindustrie und andere Hochtechnologieanwendungen. Shin-Etsu Chemical Co., Ltd., Tokyo, Japan Shin-Etsu Chemical is the world leading manufacturer of cellulose ethers according to GMP requirements for pharmaceutical- and food-applications as well as other high-tech applications. Stroever GmbH & Co. KG, Bremen, Deutschland Europäischer Hersteller von Schellackspezialitäten für die pharmazeutische Industrie und Lebensmittelindustrie sowie besonders für Nutraceuticals. Stroever GmbH & Co. KG, Bremen, Germany European manufacturer of shellac for pharmaceutical- and food industry as well as nutraceuticals. Wealthy Chemical Industry (Suzhou) Co.,Ltd., Suzhou, VR China Hersteller von pharmazeutischen Hilfsstoffen. Liefert Natrium-Carboxymethylcellulose (CMC) in pharmazeutischer Qualität. Wealthy Chemical Industry (Suzhou) Co.,Ltd., Suzhou, PR China Manufacturer of pharmaceutical excipients. Supplies sodium Carboxy Methyl Cellulose (CMC) for various pharmaceutical applications.

16 Quick References A - Z Deutsch English A B C D Aqoat 13, 20, 24, 25, 26, 27 Aquagold 13 Augentropfen 19 Befilmungssysteme 12, 13, 24, 25 Behenate 17, 20 β-cyclodextrin (β - CD) 17, 20, 24, 25, 26, 27 Bioverfügbarkeit 21 Carboxymethylcellulose (CMC) 23, 24, 25, 26, 27 Cellets 18, 24, 25 Cellulosederivate Crosslinked PVP (PVPP-CL) 17, 24, 25, 26, 27 Di-Calciumphosphat (DCPA) 17, 24, 25, 26, 27 L M N Laurate 20, 23 L-HPC 16, 17, 18, 24, 25, 26, 27 Magnesiumaluminosilicat 17, 24, 25, 26, 27 Medicated Chewing Gum 16, 24, 25 Methylcellulose (MC) 12, 18, 23, 24, 25, 26, 27 Metolose 12, 13, 14, 18, 20, 23, 24, 25, 26, 27 Metolose 60SH-Typen 14, 24, 25, 26, 27 Metolose 65SH-Typen 14, 24, 25, 26, 27 Metolose 90SH-Typen 14, 24, 25, 26, 27 Metolose SM-Typen 12, 13, 16, 18, 23, 24, 25, 26, 27 Natrium-Carboxymethylcellulose (Na-CMC) 23, 24, 25, 26, 27 Natriumhydroxid Pellets 28, 29 Neusilin 17, 24, 25, 26, 27 Neutralpellets 19, 24, 25 A B C D Aqoat 13, 20, 24, 25, 26, 27 Aquagold 13 Aqueous Shellac Solution 13, 24, 25 Behenate 17, 20 β-cyclodextrin (β - CD) 17, 20, 24, 25, 26, 27 Bioavailability 21 Capsules (Gelatin, HPMC) 22 Carboxy Methyl Cellulose (CMC) 23, 24, 25, 26, 27 Cellets 18, 24, 25 Cellulose Derivatives Crosslinked PVP (PVPP-CL) 17, 24, 25, 26, 27 Di-Calcium Phosphate (DCPA) 17, 24, 25, 26, 27 M N O Magnesium aluminosilicate 17, 24, 25, 26, 27 Medicated Chewing Gum 16, 24, 25 Methyl Cellulose (MC) 12, 18, 23, 24, 25, 26, 27 Metolose 12, 13, 14, 18, 20, 23, 24, 25, 26, 27 Metolose 60SH-Types 14, 24, 25, 26, 27 Metolose 65SH-Types 14, 24, 25, 26, 27 Metolose 90SH-Types 14, 24, 25, 26, 27 Metolose SM-Types 12, 13, 16, 18, 23, 24, 25, 26, 27 Neusilin 17, 24, 25, 26, 27 Neutral Pellets 19, 24, 25 Oleate 20, 24, 25 Ophthalmic Applications 19 Oral Disintegrating Tablets 17, 24, 25, 26, 27 E F G H K Ethylcellulose (EC) 12, 24, 25, 26, 27 EuRelease 15 F-Melt 17, 24, 25, 26, 27 Fujicalin 17, 24, 25, 26, 27 Gohsenol 12, 13, 18, 19, 24, 25, 26, 27 Health in Gum (HiG) 16, 24, 25 Hydroxypropylcellulose (HPC) 16, 17, 18, 19, 24, 25, 26, 27 Hydroxypropylcellulose, niedrig substituiert (L-HPC) 16, 17, 18, 19, 24, 25, 26, 27 Hydroxypropylmethylcellulose (HPMC) 12 15, 18 20, Hydroxypropylmethylcellulose-Acetat-Succinat (HPMC-AS) 13, 20, 24, 25, 26, 27 Hydroxypropylmethylcellulose-Phthalat (HPMC-P) 13, 20, 24, 25, 26, 27 Hypromellose 12, 13, 14, 15, 18, 20, 24, 25, 26, 27 Hypromellose-Acetat-Succinat 13, 20, 24, 25, 26, 27 Hypromellose-Phthalat 13, 20, 24, 25, 26, 27 Kaliumhydroxid Pellets 28, 29 Kapseln (Gelatine, HPMC) 22 O P R S T W Z Oleate 20, 24, 25 Palmitate 20, 24, 25 Pharmacoat 12, 13, 16, 18, 24, 25, 26, 27 PK-ADME 21 Polyvinylalkohol (PVA) 12, 13, 19, 24, 25, 26, 27 Polyvinylpyrrolidon (PVP) 13, 16, 18, 19, 24, 25, 26, 27 Polyethylenoxid (PEO) 15, 24, 25, 26, 27 Premixe 12, 13, 24, 25 Ryoto Zuckerester 17, 20, 24, 25, 26, 27 Schellack 13, 24, 25 Schnellzerfallende Tabletten 17, 24, 25, 26, 27 Stearate 17, 20, 24, 25 Surfactants 20, 24, 25 Tablettierung öliger Zubereitungen 17 Transdermale Systeme 19 Wässrige Schellack-Lösung 13, 24, 25 Zuckerester 17, 20, 24, 25, 26, 27 E F G H L Ethyl Cellulose (EC) 12, 24, 25, 26, 27 EuRelease 15 F-Melt 17, 24, 25, 26, 27 Film Coating Systems 12, 13, 24, 25 Fujicalin 17, 24, 25, 26, 27 Gohsenol 12, 13, 18, 19, 24, 25, 26, 27 Health in Gum (HiG) 16, 24, 25 Hydroxypropyl Cellulose (HPC) 16, 17, 18, 19, 24, 25, 26, 27 Hydroxypropyl Cellulose, low substituted (L-HPC) 16, 17, 18, 24, 25, 26, 27 Hydroxypropyl Methyl Cellulose (HPMC) 12 15, 18 20, Hydroxypropyl Methyl Cellulose Acetate Succinate (HPMC-AS) 13, 20, 24, 25, 26, 27 Hydroxypropyl Methyl Cellulose Phthalate (HPMC-P) 13, 20, 24, 25, 26, 27 Hypromellose 12, 13, 14, 15, 18, 20, 24, 25, 26, 27 Hypromellose Acetate Succinate 13, 20, 24, 25, 26, 27 Hypromellose Phthalate 13, 20, 24, 25, 26, 27 Laurate 20, 23 L-HPC 16, 17, 18, 24, 25, 26, 27 P R S T Palmitate 20, 24, 25 Patch Systems 19 Pharmacoat 12, 13, 16, 18, 24, 25, 26, 27 PK-ADME 21 Polyethylene Oxide (PEO) 15, 24, 25, 26, 27 Polyvinyl Alcohol (PVA) 12, 13, 24, 25, 26, 27 Polyvinylpyrrolidone (PVP) 16, 18, 19, 24, 25, 26, 27 Potassium Hydroxide Pellets 28, 29 Premixes 12, 13, 24, 25 Ryoto Sugar Ester 17, 20, 24, 25, 26, 27 Shellac 13, 24, 25 Sodium Carboxy Methyl Cellulose (CMC) 23, 24, 25, 26, 27 Sodium Hydroxide Pellets 28, 29 Stearate 17, 20, 24, 25 Sugar ester 17, 20, 24, 25, 26, 27 Surfactants 20, 24, 25 Tabletting of Oily Formulations 17