High value mineral salts. Mineral salts for the Pharmaceutical Industry

Transcription

1 High value mineral salts Mineral salts for the Pharmaceutical Industry

2 Company profile Founded in 1886, family-owned company in 4 th generation 2 production sites in Germany Turnover 100 million p.a. Employees: 500 DPL

3 Global Business Main manufacturing plant in Emmerthal 2 nd manufacturing plant in Lüneburg Sales offices in New York and Singapore Customer support center in Bratislava, Slovakia DPL

4 Regions Middle and South America North America Rest of Europe Africa Middle East Australia + New Zealand Asia Germany incl. indirect exports EU + Switzerland Thanks to over 70 distribution partners, our products are available in over 100 countries. DPL

5 Our core business Production of more than 400 mineral salts Focus on higher qualities (chem.pure, food, pharma grades) Customized product modifications and development More than product specifications Full documentation service Long term supply guarantee DPL

6 Markets Technical Industries Pharma & Cosmetics Food & Animal Nutrition 6

7 M A R K E T S & M A I N A P P L I C A T I O N S Pharma & Cosmetics Electrolytes for Nutritional supplements Magnesium for Antacids & laxatives Actives for skin & oral care products Food & Animal Nutrition Actives for Infant nutrition Ingredients for food fortification Food additives acid regulation, preservation, anti-lumping Technical Industries Additives for construction materials Process and reaction catalysts Additives for plastic industry DPL

8 What we do Since 129 years we have specialized in the production of mineral salts in high quality! Minerals - Aluminum - Ammonium - Calcium - Chromium - Copper - Iron - Lithium - Magnesium - Manganese - Molybdenum - Potassium - Sodium - Selenium - Strontium - Zinc Salts - Acetates - Aspartates - Carbonates - Citrates - Fumarates - Gluconates - Glycerophosphates - Hydroxides - Lactates - Malates - Oxalates - Oxides - Peptonates - Peroxides - Pidolates - Phosphates - Pyrophosphates - Saccharates - Succinates - Sulfates - Tartrates 8

9 Certificates und documentation Certificates GMP for APIs ISO 9001 Kosher Halal Responsible Care Certificates Documentation Documentation Specifications Product data sheet MSDS Nutritional Data Sheet Allergen Statement GMO Statement BSE / TSE Statement HACCP Statement Environment Statement 9

10 Pharma + Food supplements: Regulatory documentation - ASMFs and CEPs We offer documentation service for the registration of pharmaceuticals and provide numerous ASMFs in CTD-format. Lohmann holds CEPs for following mineral salts: Calcium Acetate, anhydrous Cert. No. R0-CEP Rev 00 Ferrous Gluconate Cert. No. R1-CEP Rev 00 Ferrous Fumarate Cert. No. R1-CEP Rev 00 Ferrous Sulphate, dried Cert. No. R0-CEP Rev 01 Ferrous Sulphate Heptahydrate Cert. No. R0-CEP Rev 00 Magnesium Aspartate Dihydrate Cert. No. R0-CEP Rev 00 Magnesium Carbonate, heavy Cert. No. R0-CEP Rev 00 Magnesium Carbonate, light Cert. No. R0-CEP Rev 00 Magnesium Citrate, anhydrous Cert. No. R0-CEP Rev 00 Magnesium Citrate, Nonahydrate Cert. No. R0-CEP Rev 0 10

11 Our special products : DC Granulates Granulated mineral salts specifically for direct compression Products: Calcium Carbonate DC Tricalcium Citrate DC Ferrous Fumarate DC Magnesium Carbonate DC Magnesium Hydroxide DC Timagnesium Dicitrate DC Magnesium Lactate DC Benefits: direct compression reduction of manufacturing costs and time excellent tabletting properties solid tablets easier dosage and handling reduced loss, saving of costs 11

12 Our special products : Microencapsulated Mineral Salts Reactive and intensive-tasting mineral salts are covered with a layer of vegetable fat in order to receive a stable and well-tasting final product Benefits: Products and Concepts: Ferrous Fumarate Ferrous Sulfate Ferrous Pyrophosphate Copper Sulfate Magnesium Oxide Zinc Oxide prevention of interactions with other components extension of shelf-life avoidance of discoloration as well as excellent taste masking properties attractive final products ensure controlled release of minerals within the digestive system 12

13 Our special products : Triturations Trace elements diluted in an inert carrier material (e.g. Calcium Carbonate, Maltodextrine) can be used in premixes or for direct fortifications Products: Selenium 0.5% Iodine 1% Chromium 1% Molybdenum 1% Fluor 1% Benefits: compared to pure substances: safe handling security of employees easy dosing reduction of production costs direct application and processing saving of time 13

14 What is additionally possible customer Finemilling Micronisation Compaction Granulation Micro-encapsulation Premixing (mineral blends) Bulk density modification Dilution Development of new products Improvement of products New products Modification of products DPL

15 Our mineral salts in the pharmaceutical industry Our mineral salts apply numerously in the pharmaceutical industry: Prevention and therapy of mineral deficiencies As antacides and laxatives As phosphate binders As topical agents As excipients Others (e.g. raw material for API synthesis) 15

16 Therapeutic areas Bones and Muscles Kidney health Gastrointestinal health Heart health Blood Brain health Immune health DPL

17 Prevention and therapy of a mineral-deficit Main product lines: Iron: global market leader due to a wide range of products Magnesium: increasing demand in well developed countries interesting as well: Calcium Copper Manganese Selenium Zinc 17

18 Iron Compounds in Pharmaceutical Application 129 years of experience at Dr. Paul Lohmann in Iron Supplementation DPL

19 Lohmann s Iron Compounds Ferrous, Ferric Citrates Ferric Ammonium Citrate Ferrous Fumarate Ferrous Gluconate Ferric Glycerophosphate Ferrous Lactate Ferrous, Ferric Phosphates Ferric Diphosphate (Ferric Pyrophosphate) Ferric Saccharate Ferrous Sulfate Fe II Haemoglobin DPL

20 Iron Componds Dr.Paul Lohmann s Top Products of Iron Salts Ferrous Sulfate, dried Ferrous Sulfate 7-hydrate high solubility in water high iron content good bioavailability Ferric Pyrophosphate high iron content ph-neutral whitish powder also available as micronized Ferric Pyrophosphate Micro2 Ferrous Sulfate Micro2 very small particle structure hence higher bioavailability neutral taste minor reactivity with other recipe components due to the encapsulation Micro2 = micronized & microencapsulated Ferrous Gluconate high solubility in water good bioavailability also available as micronized Ferrous Sulfate, microencapsulated Ferrous Fumarate, microencapsulated neutral taste minor reactivity with other recipe components due to the encapsulation Ferrous Fumarate high iron content very stable good bioavailability also available as micronized Ferrous Lactate high solubility in water low hygroscopicity almost neutral taste good bioavailability Ferrous Bisglycinate organic iron compound with the amino acid glycine almost neutral taste good bioavailability DPL

21 Relative Bioavailability of Iron Salts DPL

22 Magnesium compounds in Pharmaceutical Applications DPL

23 Lohmann s Magnesium Compounds Organic salts: Magnesium Acetate Magnesium Aspartates Magnesium Citrates Magnesium Gluconate Magnesium Glycerophosphate Magnesium Lactate Inorganic salts: Magnesium Carbonate Magnesium Hydroxide Magnesium Oxide Magnesium Phosphates Magnesium Sulphate Trimagnesium Dicitrate DPL

24 Pharma Application of Magnesium Salts Prevention and Treatment of Mineral Deficiency PRODUCT Magnesium Carbonate DC Magnesium Lactate DC Trimagnesium Dicitrate DC Trimagnesium Dicitrate Magnesium L-hydrogen Aspartate Magnesium Gluconate Magnesium Glycerophosphate Magnesium Oxide Magnesium Lactate Magnesium Sulphate BENEFIT As granules for direct compresson of tablets Supplies high amount of magnesium, neutral taste Very high solubility, high bioavailability, fine granular grade Highly soluble in water, neutral taste Excellent bioavailable source of magnesium and phosphorus Rich in magnesium, ideal for tablets and sticks Extra-fine particle structure Low in endotoxins DPL

25 Gastro-intestinal agents Antiacids - Are basic compounds that neutralize the Acid in the stomach. - Prevent and relieve the pain of gastric hyperacidity and dyspepsia. Aluminium Hydroxide (slow action) Calcium Carbonate * Magnesium Carbonate (rapid action) * Magnesium Hydroxide * Magnesium Oxide Magnesium Trisilicate Magaldrate * Manufactured by Lohmann 25

26 Gastro-intestinal agents Laxatives For clinical use: Sodium Sulfate Additionally, most Magnesium salts in high doses have laxative effects (osmotic laxatives). For conventional use: Magnesium Carbonate Magnesium Citrate Magnesium Hydroxide Magnesium Sulfate 26

27 Excipients Anticaking agents Tricalcium Phosphate Magnesium Trisilicate Calcium Carbonate Magnesium Carbonate Carrier for tablets and capsules Calcium Carbonate Tricalcium Phosphate Magnesium Carbonate Magnesium Oxide Glidants Tricalcium Phosphate Magnesium Trisilicate Antimicrobial Preservative Potassium Benzoate Sodium Benzoate Sodium Propionate Emulsifiers Sodium Citrate Lubricants Calcium Stearate Magnesium Stearate Potassium Benzoate Sodium Benzoate Zinc Stearate 27

28 Mineral salts low in endotoxins DPL

29 Mineral Salts Low in Endotoxins for Injectables Range of mineral salts with very low levels of endotoxins (<6.0 EU/g). Endotoxins or pyrogens are generated, for example when gram negative bacteria decompose. These organic molecules - lipopolysaccharides can cause fever reaction. Product Applications - Solution for Injection - Solution for Infusion - Solution for : Dialysis Peritoneal Dialysis Hemofiltration - Ophthalmic preparations Low in Endotoxins: special requirements regulated by Chapter and of the European Pharmacopeia 29

30 Liquid Dosage Mineral salts low in endotoxins Product Quality Mineral content Endotoxins (LAL)* Magnesium Acetate 4-hydrate Ph.Eur. approx. 11% Mg max. 6.0 EU/g Magnesium DL-Aspartate 4-hydrate DAB approx. 6% Mg max. 6.0 EU/g Magnesium Sulfate Ph.Eur. approx. 10% Mg max. 6.0 EU/g Calcium Acetate Ph.Eur. USP approx. 24% Ca max. 6.0 EU/g Potassium Acetate Ph.Eur. approx. 40% K max. 6.0 EU/g Potassium DL-Aspartate 0.5-hydrate DAB approx. 21.5% K max. 6.0 EU/g Sodium Acetate 3-hydrate USP, Ph.Eur. approx. 17% Na max. 6.0 EU/g Monosodium Citrate anhydrous DAC approx. 10,5% Na max. 6.0 EU/g Trisodium Citrate 2-hydrate USP, Ph.Eur. approx. 23.5% Na max. 6.0 EU/g Sodium Glycerophosphate Ph.Eur. approx. 15 % Na max. 6.0 EU/g Sodium Lactate Solution 52%, DL-LA Ph.Eur approx. 10,5 % Na max. 6.0 EU/g Sodium Lactate Solution 50%, L-LA USP, Ph.Eur. approx. 10 % Na max. 6.0 EU/g Sodium Lactate Solution 60%, L-LA USP approx. 12,5 % Na max. 6.0 EU/g Sodium Succinate 6-hydrate Chem.pure approx. 8,5 % Na max. 6.0 EU/g DPL LA-lactic acid 30

31 Prevention and treatment of mineral deficiencies Factors that influence the choice of the Mineral Salt Intended pharmaceutical dosage form Metal content* Bioavailability Solubility* Pharmacopoeia* Appearance (particle structure and size)* Taste and Colour* Price * See our Ca-, Fe-, Mg-brochures DPL

32 I N N O V AT I O N - T H E K E Y O F D r. P AU L LO H M A N N A new R&D Laboratory was inaugurated in 2008 High development capacity for mineral salts Application development for our clients Main focus Product adaptations for pharma applications New mineral salts Product modifications and applications for the food industry DPL

33 Distribution of our products in Poland Our valuable and official distribution partner for Poland DPL

34 High value mineral salts T H A N K YOU F O R Y O U R A T T E N T I O N