5/13/2010 1 Excipient Fest Porto Rico May 2010 MEGGLE Excipients & Technology, Wasserburg Germany Dr. Franz Karl Penz Location 5/5/2010 | ExcipientFest Puerto Rico 2 Meggle headquarters, Wasserburg Germany PDF created with pdfFactory Pro trial version www.pdffactory.com
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Excipient Fest Porto Rico May 2010 - IPEC-Americasipecamericas.org/sites/default/files/conference10/Franz...Tablets with Extractum Hippocastani 5/5/2010 | ExcipientFest Puerto Rico
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Founded in 1977 and situated in Tokyo.Sales of Functional Products, mostly Lactose.
MEGGLE USA Inc.
Founded in January 2009 and situated inWhite Plains, NY.Sales of pharmaceutical FunctionalProducts in North America.Own Production of pharmaceutical Lactosein USA, Minneapolis (La Sueur), MN at the beginning of 2011.
FormulaB LLC
Centre of Excellence for the pharmaceutical Industry in the Ukrainian town of Odessa.Founded in 2005, it offers research, development and design of solid dosage formulations.
Representative Office MEGGLE Shanghai
Founded in 2002 and situated in Shanghai. High demand for pharmaceutical Lactose inthe Chinese market.
MEGGLE Singapore Ltd.
Founded in 2003 and situated in Singapore.Sales of pharmaceutical Functional Products inSouth East Asia.
MEGGLE International (Pharma)
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History
Lactose for pharmaceutical use
1950 In the middle of the fifties MEGGLE decided to adopt the standards of the pharmacopeias for Lactose
1970 Tablettose® In the middle of the seventies the first agglomerated Lactose grade for Direct Compression (DC) was developed
1980 FlowLac ® In the beginning of the eighties spray-dried Lactose was introduced
Cellactose® At the end of the eighties we created ourfirst co-processed excipient
1990 RetaLac® In the nineties until now extension of DC-range
2000 InhaLac® Introduction of products for Dry-Powder-Inhaler
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Separation of nonadhered particles by air jet sieving
Assay
Schmidt and Rubensdörfer, 1994, Evaluation of Ludipress as a “Multipurpose Excipient” for DC Part I:Powder Characteristics and Tabletting Properties; Drug dev. ind. Pharm. 20(18); 2899-2925
Cella
ctose
®80
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Michoel, A., Rombaut, P., Verhoye, A., 2002. Comparative evaluative of co-processed lactose and microcrystalline cellulose with their physical mixtures in the formulation of folic acid tablets. Pharm. Dev. Technol., 7(1), 79-87.
MicroceLac® 100 produced the hardest tablets with/without API
Tabletting behaviour and dissolution ofTheophylline (98 mg) in a tablet formulationin the presence of 0.5% of Mg-stearate,using 8 mm punches (weight 400mg).
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Reta
Lac®
Characteristics
n Enables direct compression of sustained release formulations
n Superior compressibility to physical mixture, minimizes friability
n Structured surface, good flowability
n Low/medium (up to 50%) dosage formulation
n Improves wettability of HPMC
n Applications:
– Direct compression of sustained release formulations
– Facilitates preparation of dispersions containing HPMC/Lactose
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Reta
Lac®
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Compaction profile of various co-processed materials, open symbols lubricated with Mg-stearate 1% and unlubricated (closed symbols): , Cellactose; , Ludipress; , Pharmatose DCL 40.
Pharm. Powder Compaction Technology, ed. G. Alderborn and C. Nyström Vol. 71; pp. 485
Characteristics
n High dilution potential
n High tablet strength, low friability
n Spherical form, good flowability, narrow PSD
n Not sensitive to level of lubriction
n Low moisture uptake (<1% at 20oC / 80% RH)
n Sweet taste, impacts a cooling sensation
n Applications:
– Conventional tablets, chewable tablets, high dosage formulations
Source: technical brochure DFE
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Pharm
ato
se®
DCL
40
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