Losartan potassium (Form I, Dr. Reddy’s Laboratories, Jinnaram Mandal, Telangana, India), silicified microcrystalline cellulose (PROSOLV® SMCC 50, JRS Pharma, Rosenberg, Germany), copovidone (Kollidon® VA 64 (Fine), BASF Pharma, Ludwigshafen, Germany), crospovidone (Kollidon® CL, BASF, Ludwigshafen, Germany), dicalciumphosphate anhydrous (DI-CAFOS® A 150, Chemische Fabrik Budenheim, Budenheim, Germany), lactose (Tablettose® 80, Flowlac® 100, MEGGLE, Wasserburg am Inn, Germany), isomalt (galenIQTM 721, BENEO-Palatinit, Mannheim, Germany), microcrystalline cellulose (VIVAPUR® 102, JRS Pharma, Rosenberg, Germany), Ludipress® (BASF Pharma, Ludwigshafen, Germany), magnesium stearate (Parteck® LUB MST, Merck, Darmstadt, Germany), sodium stearyl fumarate (PRUV®, JRS Pharma, Rosenberg, Germany), talc (Talkum® Pharma G, C.H. Erbslöh, Krefeld, Germany), HPMC (PHARMACOAT® 603, Shin-Etsu Chemical, Tokyo, Japan), macrogol (PEG 6000, BASF Pharma, Ludwigshafen, Germany), methanol (HPLC grade, VWR Chemicals, Radnor, PA, USA), acetonitrile (HPLC grade, Honeywell, Charlotte, NC, USA), phosphoric acid (Merck, Darmstadt, Germany), monobasic potassium phosphate (Fisher Scientific, Waltham, MA, USA), disodium hydrogen phosphate anhydrous (AppliChem, Darmstadt, Germany), and sodium hydroxide solution 1 N (Merck, Darmstadt, Germany) were used.
Parteck lub mst
Manufactured by Merck Group
Sourced in Germany
Parteck® LUB MST is a lubricant for pharmaceutical processing equipment. It is designed to reduce friction and wear in various types of processing machinery.
Automatically generated - may contain errors
Lab products found in correlation
Vivapur 102, by JRS Pharma (5 mentions)
Pharmacoat 603, by Shin-Etsu Chemical (2 mentions)
Potassium phosphate monobasic, by Thermo Fisher Scientific (1 mentions)
Sodium hydroxide solution 1 n, by Merck Group (1 mentions)
Phosphoric acid, by Merck Group (1 mentions)
Kollidon cl, by BASF (1 mentions)
Hplc grade acetonitrile, by Honeywell (1 mentions)
Kollidon va64 fine, by BASF (1 mentions)
Sald 2100, by Shimadzu (1 mentions)
Methocel k4m, by Colorcon (1 mentions)
Ipratropium bromide, by Boehringer Ingelheim (1 mentions)
9 protocols using parteck lub mst
1
Formulation and Characterization of Losartan Potassium Tablets
2
Microcrystalline Cellulose and Lactose Tableting
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The microcrystalline cellulose (MCC, Vivapur 102, JRS Pharma, Troisdorf, Germany) was selected as a plastically deformable material and lactose (FlowLac 100, Meggle, Wasserburg am Inn, Germany) as a more brittle material. Lactose was blended with magnesium stearate (Parteck LUB MST, Merck, Darmstadt, Germany) before tableting (Section 2.7 ). All materials were stored at 21 °C and 45% relative humidity under controlled conditions at least one week before use to allow for equilibration. All prepared ribbons, granules and tablets were also stored for at least one week under these controlled conditions prior to analysis.
3
Excipient Characterization for Tableting
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Four different excipients were investigated. Microcrystalline cellulose (Vivapur 102, JRS Pharma, Germany), lactose (Tablettose® 80, Meggle, Germany), isomalt (galenIQ™721, BENEO-Palatinit, Germany) and Ludiflash®, a co-processed excipient based on d -Mannitol, crospovidone and a polymer dispersion of polyvinyl acetate (BASF, Germany). External lubrication was applied using magnesium stearate (Parteck® LUB MST, Merck, Germany) or sodium stearyl fumarate (PRUV®, JRS Pharma, Germany).
4
Mechanofusion and High-Shear Coating of Inhalation Lactose
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As the model carrier in the coating processes, InhaLac® 230 (Meggle, Wasserburg, Germany) a crystalline, sieved inhalation grade lactose monohydrate was used. Magnesium stearate (Parteck® LUB MST, Merck, Darmstadt, Germany) served as the model coating material. For the sake of simplicity, the materials are shortened to the following: InhaLac 230 (IH230), magnesium stearate (MgSt), InhaLac 230 processed in the mechanofusion reactor (IH230AMS, suffix “+” or “−” indicating if processed with the additive or without), InhaLac 230 processed in the high-shear mixer (IH230HSM, suffix “+” or “−” indicating if processed with the additive or without). Micronised ipratropium bromide served as the model drug (d90 < 5 µm, Boehringer Ingelheim Pharma AG & Co. KG, Ingelheim, Germany).
5
Blending and Characterization of Pharmaceutical Powders
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Microcrystalline cellulose (PH-101, Asahi Kasei Corp., Japan), milled lactose monohydrate (Pharmatose Ⓡ 80M, DFE Pharma, Germany), lactose hydrate prepared by fluidized bed granulation (Dilactose Ⓡ S, FREUND Corp., Japan), and magnesium stearate (Parteck LUB MST, Merck KGaA, Germany) were used in this study. The medium diameters were measured using a laser diffraction particle analyzer (SALD 2100, Shimadzu Corp.) and true densities of the powder materials were obtained by the literature (Table 1). [31] [32] [33] [34] [35] Four types of sample powders were used in this study: milled lactose hydrate (Lac), microcrystalline cellulose (MCC), a mixed powder of Lac and MCC with 95 wt% of Lac (Lac/MCC), and lactose hydrate prepared by fluidized bed granulation (DiLac).
Lac was the non-modified lactose monohydrate with a relatively large particle size. DiLac was the lactose granule for direct compression. Magnesium stearate (0.5 wt%) was used as a lubricant.
Powder samples were manually blended in a polyethylene bag for 5 min.
Lac was the non-modified lactose monohydrate with a relatively large particle size. DiLac was the lactose granule for direct compression. Magnesium stearate (0.5 wt%) was used as a lubricant.
Powder samples were manually blended in a polyethylene bag for 5 min.
6
Metformin Quasi-Emulsion Tablet Formulation
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Metformin hydrochloride (MF, Auro Laboratories Ltd., Mumbai, India) was dissolved in demineralized water and crystallized in technical-grade acetone (density used for calculations: 0.784 g/mL at 25 °C [14 (link)]). Two types of hypromellose (HPMC, Pharmacoat® 603, Shin-Etsu Chemical Co., Ltd., Tokyo, Japan, and Methocel™ K4M, Colorcon, Dartford, UK) were used as polymeric stabilizers of the quasi-emulsion.
For tableting, hyprolose (HPC SSL SFP, Nippon Soda, Tokyo, Japan) was used as a dry binder, and magnesium stearate (Parteck® LUB MST, Merck KGaA, Darmstadt, Germany) as a lubricant.
Caffeine (BASF, Ludwigshafen, Germany) was used as a tracer, to determine the residence time distribution.
For tableting, hyprolose (HPC SSL SFP, Nippon Soda, Tokyo, Japan) was used as a dry binder, and magnesium stearate (Parteck® LUB MST, Merck KGaA, Darmstadt, Germany) as a lubricant.
Caffeine (BASF, Ludwigshafen, Germany) was used as a tracer, to determine the residence time distribution.
7
Carrier Modification of Inhalable Lactose
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The first section of this study covers the carrier modification of a specific respiratory grade, sieved lactose quality, namely InhaLac® 230 (IH230, Meggle, Wasserburg, Germany), using magnesium stearate (MgSt, Parteck® LUB MST, Merck, Darmstadt, Germany) and poloxamer 188 (Pol, Lutrol® micro 68, BASF, Ludwigshafen, Germany). To produce engineered fine excipients, we used the micronised, respiratory-grade lactose InhaLac 400 (IH400, Meggle) in combination with MgSt or Pol. IH230, after the removal of the present intrinsic fines (IH230rF), served as carrier material for ternary blends. Ipratropium bromide (d90 < 5 µm, Boehringer Ingelheim, Ingelheim, Germany) and fenoterol hydrobromide (d90 < 5 µm, Boehringer Ingelheim) were used as model drugs.
8
Evaluating Plastically Deforming Excipients for Tableting
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Microcrystalline cellulose (MCC, Vivapur® 102, JRS Pharma, Germany) was used as a plastically deforming excipient in experiments studying varying process parameters.
For various experiments, magnesium stearate (Parteck LUB MST, Merck, Germany) was added at 1% for lubrication. To avoid sticking of the material to the rolls, magnesium stearate was mixed with formulation components in a bin blender (LM 40, L.B. Bohle Maschinen + Verfahren GmbH, Germany) for 3 min at 20 rpm. In some experiments the behavior of over-lubricated mixtures was studied. These were produced by increasing the mixing time to 20 min.
For studies using an API in a formulation, 25% Diclofenac (Amoli Organics Pvt. Ltd., India), 60% MCC and 14% anhydrous β-lactose (SuperTab® 21AN, DFE Pharma, Germany) were blended for 20 min at 20 rpm. Afterwards, 1% magnesium-stearate was added and blended for another 3 min.
For various experiments, magnesium stearate (Parteck LUB MST, Merck, Germany) was added at 1% for lubrication. To avoid sticking of the material to the rolls, magnesium stearate was mixed with formulation components in a bin blender (LM 40, L.B. Bohle Maschinen + Verfahren GmbH, Germany) for 3 min at 20 rpm. In some experiments the behavior of over-lubricated mixtures was studied. These were produced by increasing the mixing time to 20 min.
For studies using an API in a formulation, 25% Diclofenac (Amoli Organics Pvt. Ltd., India), 60% MCC and 14% anhydrous β-lactose (SuperTab® 21AN, DFE Pharma, Germany) were blended for 20 min at 20 rpm. Afterwards, 1% magnesium-stearate was added and blended for another 3 min.
9
Microcrystalline Cellulose-based Placebo Formulations
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Microcrystalline cellulose (MCC, Vivapur® 102, JRS Pharma, Germany) was used as primary excipient in experiments studying varying process parameters.
Different placebo formulations were prepared. Excipients used were lactose (Granulac® 200, Meggle, Germany) and magnesium stearate (Parteck® LUB MST, Merck, Germany).
Different placebo formulations were prepared. Excipients used were lactose (Granulac® 200, Meggle, Germany) and magnesium stearate (Parteck® LUB MST, Merck, Germany).
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