Pitavastatin calcium (PITA) and Lipidalon® tablets (1 mg) were a kind gift sample from Mash Premiere for Pharmaceutical Industry (New Cairo, Egypt). Lornoxicam (form II) (LORNO) and Lornoxicam® tablets (4 mg) were obtained as a gift sample from Global Napi drug company Ltd (6th October City, Egypt). Pharmaburst® 500 and Lubripharm® Ssf (sodium stearyl fumarate) were a gift from SPI Pharma (Wilmington, DE, USA). F-melt® Type C was provided by Fuji Chemical Industry Ltd. (Toyama-Pref, Japan). Prosolv ODT G2® and Prosolv HD 90® were a gift from JRS Pharma GmbH and Co., KG (Rosenberg, Germany). Ludiflash® was provided by BASF (Ludwigshafen, Germany). Lactochem® Microfine was a gift sample from (Borculo Domo, Netherlands). Starlac® and Pearlitol flash® were obtained from Roquette (Lestrem, France). Mannitol, potassium dihydrogen phosphate, and disodium hydrogen phosphate were purchased from (El-Nasr Pharmaceutical Chemicals Co., Cairo, Egypt). Diethyl ether was from (El-Goumhouria Co., Cairo, Egypt). Torsemide (internal standard) was purchased from (Multi-Apex Pharma, Cairo, Egypt). Acetonitrile, ammonium acetate, and ethyl acetate (HPLC grade) were from Merck (Darmstadt, Germany).
Pearlitol flash
Manufactured by Roquette
Sourced in France
Pearlitol flash is a laboratory equipment product from Roquette. It is designed for the flash drying of various materials. The equipment utilizes high-speed airflow to rapidly dry the sample, preserving its physical and chemical properties.
Automatically generated - may contain errors
Lab products found in correlation
Starlac, by Roquette (2 mentions)
Starch 1500, by Colorcon (2 mentions)
Prosolv odt g2, by JRS Pharma (1 mentions)
Ethyl acetate hplc grade, by Merck Group (1 mentions)
Prosolv hd 90, by JRS Pharma (1 mentions)
Ludiflash, by BASF (1 mentions)
Acetonitrile, by Merck Group (1 mentions)
Ammonium acetate, by Merck Group (1 mentions)
Sodium phosphate, by Merck Group (1 mentions)
Gentamicin, by Thermo Fisher Scientific (1 mentions)
Hplc grade methanol, by Thermo Fisher Scientific (1 mentions)
Acetonitrile acn, by Thermo Fisher Scientific (1 mentions)
Penicillin streptomycin, by Thermo Fisher Scientific (1 mentions)
Hanks balanced salt solution (hbss), by Thermo Fisher Scientific (1 mentions)
Trypsin edta solution, by Merck Group (1 mentions)
Sodium hydroxide (naoh), by Merck Group (1 mentions)
Glacial acetic acid, by Merck Group (1 mentions)
Sodium chloride (nacl), by Merck Group (1 mentions)
Dulbecco modified eagle medium (dmem), by Lonza (1 mentions)
Fetal bovine serum (fbs), by Lonza (1 mentions)
7 protocols using pearlitol flash
1
Formulation and Evaluation of Pitavastatin Calcium Tablets
2
Biorelevant Media and Cell Culture Reagents
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Isoniazid and rifampicin were purchased from Molekula Ltd (UK). Pearlitol® Flash (mannitol-starch copolymer) was obtained from Roquette Pharma (France), whilst Avicel PH-102 micro-crystalline cellulose (MCC) and sodium stearyl fumarate (SSF) were purchased from FMC BioPolymer (USA).
Biorelevant FaSSIF/FeSSIF/FaSSGF Instant Powder was purchased from biorelevant.com (UK).
Sodium hydroxide, sodium chloride, sodium phosphate and glacial acetic acid for biorelevant media were obtained from Sigma-Aldrich (UK). Acetonitrile (ACN) and methanol (HPLC-grade) were obtained from Fisher Scientific (UK).
For cell culture media DMEM was purchased from Lonza (UK), fetal bovine serum (FBS), gentamicin (10 mg/ml), Fungizone (amphotericin B 250 μg/ml), HBSS and penicillin/streptomycin (10,000 U/ml) were all purchased from Gibco (Thermo Fischer Scientific, UK). Trypsin-EDTA solution (0.25%) was procured from Sigma-Aldrich (UK).
Biorelevant FaSSIF/FeSSIF/FaSSGF Instant Powder was purchased from biorelevant.com (UK).
Sodium hydroxide, sodium chloride, sodium phosphate and glacial acetic acid for biorelevant media were obtained from Sigma-Aldrich (UK). Acetonitrile (ACN) and methanol (HPLC-grade) were obtained from Fisher Scientific (UK).
For cell culture media DMEM was purchased from Lonza (UK), fetal bovine serum (FBS), gentamicin (10 mg/ml), Fungizone (amphotericin B 250 μg/ml), HBSS and penicillin/streptomycin (10,000 U/ml) were all purchased from Gibco (Thermo Fischer Scientific, UK). Trypsin-EDTA solution (0.25%) was procured from Sigma-Aldrich (UK).
3
Formulation and Evaluation of Ibuprofen ODT
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Nurofen Meltlets (A marketed ibuprofen 200 mg ODT) and standard immediate release paracetamol tablets were obtained from Reckitt Benckiser (Slough, UK) and Wockhardt (Wrexham, UK) respectively.
Materials for placebo ODT preparation included D-mannitol (Sigma-Aldrich, UK), Microcrystalline Cellulose (MCC) (Avicel PH102, FMC Biopolymer, USA), Partially Pregelatinised Maize Starch (Starch 1500®, Colorcon Inc., USA), crospovidone (Kollidon CL, BASF, Germany), Pearlitol Flash (Roquette, France), sodium stearyl fumarate (Alubra, FMC Biopolymer, USA) and magnesium stearate (Fischer Scientific, UK). Hydroxypropyl methylcellulose (HPMC) (METHOCEL™ K100M, provided by Colorcon Inc., UK) was used to manufacture hydrophilic matrix tablets.
Materials for placebo ODT preparation included D-mannitol (Sigma-Aldrich, UK), Microcrystalline Cellulose (MCC) (Avicel PH102, FMC Biopolymer, USA), Partially Pregelatinised Maize Starch (Starch 1500®, Colorcon Inc., USA), crospovidone (Kollidon CL, BASF, Germany), Pearlitol Flash (Roquette, France), sodium stearyl fumarate (Alubra, FMC Biopolymer, USA) and magnesium stearate (Fischer Scientific, UK). Hydroxypropyl methylcellulose (HPMC) (METHOCEL™ K100M, provided by Colorcon Inc., UK) was used to manufacture hydrophilic matrix tablets.
4
Tablet Disintegration Study: Varying Formulations
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A total of five different powder blends were prepared, with four blends compressed at two different compression forces and the fifth blend compressed using only one force (Table 1 ), giving a total of nine different batches of tablets. Tablets were composed of Pearlitol Flash (Roquette, Lestrem, France), Starch 1500 (Colorcon Inc., Harleysville, USA) and magnesium stearate (Fischer Scientific, Loughborough, UK) (Table 1 ). Excipient concentration and compression force was varied to obtain tablets of differing disintegration times, to allow for a wide range of times to be compared between the in vivo disintegration times and the times obtained for the in vitro methods.
Tablet formulation details for the 9 batches of tablets utilised in the in vivo disintegration study.
| Formulation | Batch | Pearlitol Flash (%) | Starch 1500 (%) | magnesium stearate (%) | Compression Force (KN) |
|---|---|---|---|---|---|
| Powder Blend 1 | B1 | 99.5 | — | 0.5 | 4 |
| B2 | 9.5 | ||||
| Powder Blend 2 | B3 | 89 | 10 | 1 | 9.5 |
| B4 | 22 | ||||
| Powder Blend 3 | B5 | 79 | 20 | 1 | 20 |
| B5 | 46 | ||||
| Powder Blend 4 | B7 | 49.5 | 49.5 | 1 | 26 |
| B8 | 57 | ||||
| Powder Blend 5 | B9 | 24.5 | 74.5 | 1 | 32 |
Each powder blend, except powder blend 5, were compressed at two different compression forces to provide tablets of different disintegration/hardness profiles.
5
Formulation and Evaluation of FBP-RHCl Tablets
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Flurbiprofen (FBP) and ranitidine HCl (RHCl) was obtained from Axis Pharmaceuticals (Pakistan). Lycoat® RS780 and Pearlitol Flash® (Mannitol Starch) were received as gift samples from Roquette Frères (France). Polyvinyl alcohol (PVA 1500), polyethylene glycol (PEG 400), propylene glycol (PG), and dichloromethane (DCM) were obtained from Daejung Chemicals and Metals Co., Ltd. (Siheung, Republic of Korea). Glycerin (GLY) was obtained from Sigma-Aldrich (Darmstadt, Germany). All other excipients and chemicals were of an analytical grade.
6
Formulation Development of Orally Disintegrating Tablets
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Aquacoat® ECD was donated from FMC BioPolymer, Newark, NJ, USA. Surelease® E-7-19040 was given from Colorcon Inc., Harleysville, PA, USA. Parteck® ODT was received from Merck KGaA, Darmstadt, Germany. SmartEx® QD-50 was handed over from Shin-Etsu Chemical Co., Ltd., Tokyo, Japan. F-Melt C was purchased from Fuji Chemical Industry Co., Ltd., Toyama, Japan. Pearlitol® Flash was a gift from Roquette, Lestrem, France. Magnesium stearate and methylene blue were acquired from POCh, Piekary Śląskie, Poland. RUP was procured from Xi’An Kerui Biotechnology Co., Ltd., Xi’An, China.
7
Formulation and Evaluation of Glimepiride Tablets
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Glimepiride was kindly supplied by Sedico Pharmaceuticals, Giza, Egypt. Sodium Lauryl Sulphate (SLS) was purchased from El-Nasr Pharmaceutical Chemicals Co., Cairo, Egypt. Pregelatinized starch (PreGelSt) was a gift from Colorcon Limited, UK. Ac-Di-Sol (Crosscarmellose sodium) was purchased from E. Merck, Germany. Crosspovidone XL (CP) and Avicel pH 102 were purchased from FMC Corporation, Philadelphia, USA. Starlac (lactose and maize starch), Pearlitol SD (Mannitol) and Pearlitol flash (mannitol and maize starch) were a gift from Roquette, France. Gelucire 50/13 was obtained from Gattefosé, France. Colloidal Silicon dioxide (Aerosil 200) hydrophilic was obtained from Degussa, USA. Polyvinylpyrrolidone (PVP K30) was obtained from Fluka, Switzerland. Low substituted Hydroxypropylcellulose (L-HPC) was purchased from Shin-Etsu Chemical Co., Ltd Tokyo, Japan. Spray-dried lactose was a gift from Ph. Francaise Co., France. Carbon tetrachloride and magnesium stearate were obtained from El-Nasr Pharmaceutical Chemicals Company, Cairo, Egypt. Aspartame was purchased from Sigma, St.Louis, USA. Amaryl® tablets (3 mg): Batch No. 2EG008 was obtained from Sanofi-Aventis, Cairo, Egypt.
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Glimepiride was kindly supplied by Sedico Pharmaceuticals, Giza, Egypt. Sodium Lauryl Sulphate (SLS) was purchased from El-Nasr Pharmaceutical Chemicals Co., Cairo, Egypt. Pregelatinized starch (PreGelSt) was a gift from Colorcon Limited, UK. Ac-Di-Sol (Crosscarmellose sodium) was purchased from E. Merck, Germany. Crosspovidone XL (CP) and Avicel pH 102 were purchased from FMC Corporation, Philadelphia, USA. Starlac (lactose and maize starch), Pearlitol SD (Mannitol) and Pearlitol flash (mannitol and maize starch) were a gift from Roquette, France. Gelucire 50/13 was obtained from Gattefosé, France. Colloidal Silicon dioxide (Aerosil 200) hydrophilic was obtained from Degussa, USA. Polyvinylpyrrolidone (PVP K30) was obtained from Fluka, Switzerland. Low substituted Hydroxypropylcellulose (L-HPC) was purchased from Shin-Etsu Chemical Co., Ltd Tokyo, Japan. Spray-dried lactose was a gift from Ph. Francaise Co., France. Carbon tetrachloride and magnesium stearate were obtained from El-Nasr Pharmaceutical Chemicals Company, Cairo, Egypt. Aspartame was purchased from Sigma, St.Louis, USA. Amaryl® tablets (3 mg): Batch No. 2EG008 was obtained from Sanofi-Aventis, Cairo, Egypt.
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