The probiotic tablets were produced by direct compression using a single punch tablet press (MCC Corporation, NJ, US) fitted with a flat-faced bevel-edged punches with diameter of 8 mm. The probiotic powder blends consisted of 10% (w/w) spray-dried bacterial powder, 85% (w/w) filler-binder and 5% (w/w) magnesium stearate (magnesium stearate; Fagron, Nazareth, Belgium). The used direct compression filler-binders were Tablettose 100 (lactose; Meggle Pharma, Wasserburg, Germany) and Xylisorb XTAB 240 (xylitol; Roquette pharma, Zaventem, Belgium). These filler-binders were chosen based on the results of previously investigations (Byl et al., 2019b (Byl et al., , 2019a)) . The high concentration of lubricant was selected to avoid sticking to punches and die. To investigate the effect of the compression pressure on bacterial survival, the bacterial powder blends were compacted at different pressures, namely from 40 until 120 MPa.
Magnesium stearate
Manufactured by Fagron
Sourced in Spain, Belgium
Magnesium stearate is a fine, white, powder-like material. It is a commonly used excipient in pharmaceutical and dietary supplement formulations. The primary function of magnesium stearate is as a lubricant, helping to improve the flow and processing of other ingredients during manufacturing.
Automatically generated - may contain errors
Lab products found in correlation
Aerosil, by Fagron (2 mentions)
Mannitol, by Fagron (2 mentions)
Sodium hydroxide (naoh), by ITW Reagents (1 mentions)
Sodium chloride (nacl), by ITW Reagents (1 mentions)
Kh2po4, by ITW Reagents (1 mentions)
Methocel k100m cr, by Colorcon (1 mentions)
Kollidon va64, by BASF (1 mentions)
Kleptose, by Roquette (1 mentions)
Glacial acetic acid, by Merck Group (1 mentions)
Sodium acetate, by Merck Group (1 mentions)
Ferric chloride, by Merck Group (1 mentions)
6 hydroxy 2 5 7 8 tetramethylchroman 2 carboxylic acid trolox, by Merck Group (1 mentions)
2 4 6 tris 2 pyridyl s triazine tptz, by Merck Group (1 mentions)
Hydrochloric acid (hcl), by Merck Group (1 mentions)
Methanol, by Merck Group (1 mentions)
Hydrogen peroxide, by Merck Group (1 mentions)
Glutathione (gsh), by Merck Group (1 mentions)
Adenosine triphosphate (atp), by Merck Group (1 mentions)
Nadph, by Merck Group (1 mentions)
Feso4 7h2o, by Merck Group (1 mentions)
7 protocols using magnesium stearate
1
Probiotic Tablet Formulation by Direct Compression
2
Cetirizine Formulation Development and Evaluation
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The active substance used was cetirizine dihydrochloride (Jubilant Lifesciences Ltd, India; CTZ). The excipients used for the study SeDeM were talc (Fagron, Spain), magnesium stearate (Fagron, Spain), and colloidal silicon dioxide (Aerosil ®, Fagron, Spain). The excipients used in the factorial design were mannitol (Fagron, Spain) and polyvinylpyrrolidone Ph. Eur (Fagron, Spain). The reagents used for the preparation of phosphate buffers solutions (solubility studies) were: 37% HCl (Panreac, Barcelona), NaCl (Panreac, Barcelona), NaOH (Panreac, Barcelona) and KH2PO4 (Panreac, BCN).
3
Tolcapone Formulation Development and Evaluation
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The active substance under study is tolcapone (batches: SOM0114599 and SOM0714600) (CCN Industries LTD via Porschem Pharm).
The excipients studied are Vivapur® 102 (JRS, Rosenberg, Germany), Avicel® PH 101 (FMC Corp, Brusseles, Belgium), Kleptose® (ROQUETTE, Roquette Frères, Lestrem, France), Kollidon® VA 64 (BASF, Ludwigshafen, Germany), Prosolv® HD90 (JRS, Rosenberg, Germany), Isomalt® 721 (GalenIQ, Manheim, Germany), Methocel® K100M CR (Colorcon, Dartford, UK), talc (Fagron, Terrassa, Spain), magnesium stearate (Fagron, Terrassa, Spain), and colloidal silicon dioxide (Fagron, Terrassa, Spain).
The excipients studied are Vivapur® 102 (JRS, Rosenberg, Germany), Avicel® PH 101 (FMC Corp, Brusseles, Belgium), Kleptose® (ROQUETTE, Roquette Frères, Lestrem, France), Kollidon® VA 64 (BASF, Ludwigshafen, Germany), Prosolv® HD90 (JRS, Rosenberg, Germany), Isomalt® 721 (GalenIQ, Manheim, Germany), Methocel® K100M CR (Colorcon, Dartford, UK), talc (Fagron, Terrassa, Spain), magnesium stearate (Fagron, Terrassa, Spain), and colloidal silicon dioxide (Fagron, Terrassa, Spain).
4
Antioxidant Activity Assessment of Melatonin Formulation
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Melatonin was purchased from Methapharmaceutical IND S.L. (Spain). Mannitol, polyvinylpyrrolidone (crospovidone), lactose, magnesium stearate, anhydrous colloidal silica, tartaric acid and sodium bicarbonate were all supplied by Fagron Ibérica S.A.U. (Spain).
The antioxidants, vitamin C (sodium ascorbyl phosphate) and resveratrol were supplied by Fagron Ibérica S.A.U. (Spain). NADPH, adenosine triphosphate (ATP) and glutathione (GSH) were purchased from Sigma Aldrich (Spain).
For the determination of total antioxidant activity using the ferric ion reducing antioxidant power (FRAP) technique, the following were used: sodium acetate, acetic acid, 2,4,6-tris(2-pyridyl)-s-triazine (TPTZ), hydrochloric acid, ferric chloride, FeSO4 × 7 H2O and bidistilled water, purchased from Sigma Aldrich (Spain).
For the determination of total antioxidant activity using the TAC technique, the following were used: sodium acetate, bidistilled water, glacial acetic acid, hydrogen peroxide, 2,2’-azino-bis-2-ethybenzothiazoline-6-sulphonic acid (ABTS), the water-soluble analogue of vitamin E (Trolox (6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid)), ethanol, methanol and monosodium phosphate, purchased from Sigma Aldrich (Spain).
The antioxidants, vitamin C (sodium ascorbyl phosphate) and resveratrol were supplied by Fagron Ibérica S.A.U. (Spain). NADPH, adenosine triphosphate (ATP) and glutathione (GSH) were purchased from Sigma Aldrich (Spain).
For the determination of total antioxidant activity using the ferric ion reducing antioxidant power (FRAP) technique, the following were used: sodium acetate, acetic acid, 2,4,6-tris(2-pyridyl)-s-triazine (TPTZ), hydrochloric acid, ferric chloride, FeSO4 × 7 H2O and bidistilled water, purchased from Sigma Aldrich (Spain).
For the determination of total antioxidant activity using the TAC technique, the following were used: sodium acetate, bidistilled water, glacial acetic acid, hydrogen peroxide, 2,2’-azino-bis-2-ethybenzothiazoline-6-sulphonic acid (ABTS), the water-soluble analogue of vitamin E (Trolox (6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid)), ethanol, methanol and monosodium phosphate, purchased from Sigma Aldrich (Spain).
5
Analytical Method Development and Validation
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Caffeine, croscarmellose, and lactose monohydrate were supplied by Caelo (Hilden, Germany). Polyvinylpyrrolidone (PVP) 90, magnesium stearate, silica dioxide, and hydroxypropyl methylcelluose K4M (HPMC) were purchased from Fagron (Barsbüttel, Germany).
Water HiPerSolv CHROMANORM LC-MS grade (VWR international, Fontenay-sous-Bois, France), Methanol HiPerSolv CHROMANORM LC-MS grade (VWR international, Fontenay-sous-Bois, France), Formic acid (Merck KaA Gmbh, Darmstadt, Germany), Acetonitrile HiPerSolv CHROMANORM LC-MS grade (VWR international, Fontenay-sous-Bois, France), ammonium acetate (Merck KaA Gmbh, Darmstadt, Germany), completely desalinated water (based on tap water, Stadtwerke Greifswald, Germany, prepared by double reverse osmosis).
Water HiPerSolv CHROMANORM LC-MS grade (VWR international, Fontenay-sous-Bois, France), Methanol HiPerSolv CHROMANORM LC-MS grade (VWR international, Fontenay-sous-Bois, France), Formic acid (Merck KaA Gmbh, Darmstadt, Germany), Acetonitrile HiPerSolv CHROMANORM LC-MS grade (VWR international, Fontenay-sous-Bois, France), ammonium acetate (Merck KaA Gmbh, Darmstadt, Germany), completely desalinated water (based on tap water, Stadtwerke Greifswald, Germany, prepared by double reverse osmosis).
6
Carbamazepine Formulation Development
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The active pharmaceutical ingredient (API) used was carbamazepine (batches: 16CT000089 and 16CT000017), obtained from CTX Lifesciences Pvt. Limited, India.
The main excipients used were:l -HPC LH11 [(low-substituted hydroxypropylcellulose) (supplier: SHINETSU, Tokyo, Japan)]; l -HPC NBD022 [(low substituted hydroxypropyl cellulose) (supplier: SHINETSU, Tokyo, Japan)].
The adjuvant excipients used were: VIVASOL GF® [(croscarmellose) (batch: 7111601027, supplier: JRS PHARMA, Rosenberg, Germany)]; VIVAPHARM PVP PXL® [(crospovidone type A) (supplier: JRS PHARMA, Rosenberg, Germany)]; VIVAPHARM PVP PXL10® [(Crospovidone Type B) (supplier: JRS PHARMA, Rosenberg, Germany)]; PEARLITOL 200 SD® [(d -Mannitol) (supplier: ROQUETTE LAISA ESPAÑA, Valencia, Spain)]. The excipients used as lubricants and ligants were: Talc (supplier: Fagron, Barcelona, Spain); magnesium stearate (supplier: Fagron, Barcelona, Spain) and colloidal silicon dioxide (Aerosil®) (supplier: Fagron, Barcelona, Spain) as a standard lubrication blend. All components were stored at room temperature (20–30 °C).
The main excipients used were:
The adjuvant excipients used were: VIVASOL GF® [(croscarmellose) (batch: 7111601027, supplier: JRS PHARMA, Rosenberg, Germany)]; VIVAPHARM PVP PXL® [(crospovidone type A) (supplier: JRS PHARMA, Rosenberg, Germany)]; VIVAPHARM PVP PXL10® [(Crospovidone Type B) (supplier: JRS PHARMA, Rosenberg, Germany)]; PEARLITOL 200 SD® [(
7
Formulation of Probiotic Throat Lozenges
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Freeze-dried Lactobacillus rhamnosus GG (ATCC31103) was provided to us as THT 030903 by THT (Gembloux, Belgium). Subsequently, probiotic tablets were made as powder blends of freeze-dried LGG, a direct compression filler-binder and a suitable amount of lubricant to void sticking to punches and die (magnesium stearate; Fagron, Nazareth, Belgium). To target the probiotic bacteria at the pharyngeal microbiome, the probiotic bacteria were processed into a throat lozenge and an orally disintegrating tablet. Direct compression filler-binders that are suitable for these pharmaceutical dosage forms were selected and analyzed. The studied filler-binders, which are listed in table 1, were chosen to represent a range of materials with different compression behaviors (plastically or elastically deformation, fragmenting). [Table 1 near here]
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