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13 protocols using hpmc k4m

1

Sustained-Release Tablet Formulation

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Itopride hydrochloride (ITP) was kindly gifted by Abbott Laboratories (Pakistan) Limited.
Hydroxypropyl methylcellulose (HPMC-K4M, K100M) and ethylcellulose (EC-10 cps) were purchased from Colorcon Limited (Kent, England). Kollidon ® SR was provided by BASF (Ludwigshafen, Germany). Microcrystalline cellulose (MCC, Avicel pH 101) was procured from Dow Chemical Company (USA). Talc was purchased from the BDH Laboratories Suppliers, England. Magnesium stearate was provided by FMC Corporation, USA. All other materials used were analytical grades.
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2

Pharmaceutical Excipient Characterization

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HPMC-K4M and PVP-Kollidon 30 were kindly donated by Colorcon (UK) and BASF (Germany), respectively. Sodium Taurocholate with 99% purity was purchased from Prodotti chimici e alimentari SPA (Italy). Deuterium oxide with 99% purity was purchased from Apollo Scientific (UK). All reagents and chemical including sodium hydroxide with purity 97%, sodium chloride with purity 99%, sodium dihydrogen phosphate with purity 99% and glacial acetic acid with purity ≥ 99% were purchased from Sigma Aldrich (UK).
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3

Formulation and Evaluation of AZM Ocular Gel

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AZM was procured from M/s
Sun Pharma, Paonta Sahib, India. Carbopol 934P (Lot No. 9003-01-4)
(Loba Chemicals, Mumbai), HPMC K4M (Lot No. 9004-64-2) (Colorcon,
UK), SBE-β-CD (Cydex Pharmaceuticals, USA), edetate disodium
(Lot No. 6381-92-6) (Loba Chemicals, Mumbai), benzalkonium chloride
(Ases Chemicals Works, Jodhpur), citric acid (Ases Chemicals Works,
Jodhpur), disodium hydrogen phosphate (Lot No. 10028-24-7), potassium
dihydrogen orthophosphate (Lot No. 7778-77-0), and sodium hydroxide
(Lot No. 1310-73-2) were purchased from Loba Chemicals, Mumbai. Whatman’s
filter paper-41 (Lot No. WHA1441125) (M/s Whatman Int. Ltd., England), Bacillus subtilis (Cat. No. - MCC 2010; National
Centre for Microbial Resource, Pune, India), and purified water (in house laboratory) were used as is for the experiments.
Albino rabbits for testing were obtained from the central animal house,
Lachoo Memorial College of Science and Technology (Autonomous), Jodhpur,
Rajasthan.
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4

Formulation and Evaluation of Nizatidine Tablets

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Strides Pharma Science Limited (Formerly Strides Shasun Limited, Bangalore, India) provided nizatidine as a gift sample. Colorcon UK generously gifted HPMC K4M, HPMC E4M, HPMC K15 and HPMC K200M. All other tableting excipient including carbopol 934P, sodium bicarbonate, magnesium stearate and lactose were of research grade and were sourced from BDH Laboratory (UK). Hydrochloric acid (37%) was sourced from Fisher Scientific (UK). All the experiments were performed using de-ionised water that was prepared at in-house facility.
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5

Bioavailability Study of Paroxetine Hydrochloride Hemihydrate

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PHH was purchased from Zhejiang Linhai Jinqiao Chemical Co., Ltd. (Zhejiang, China). HPMC K4M was obtained from Colorcon Co., Ltd. (Shanghai, China). CMC-Na was provided by Guangzhou Qihua Medical Equipment Co., Ltd. (Guangdong, China). Polyvinylpyrrolidone (PVP K30) was purchased from International Specialty Products Inc. (Wayne, NJ, USA). Microcrystalline cellulose (MCC) and magnesium stearate were purchased from Huzhou Pharmaceuticals Co., Ltd. (Zhejiang, China). Lactose (Granulac 200) was obtained from Molkerei Meggle Wasserburg GmbH & Co. Kg. (Wasserburg, Germany). Methacrylic resin (Eudragit L30D-55) was received from Evonik Röhm GmbH (Darmstadt, Germany). The reference substance of PHH, desfluoroparoxetine and N-methyl-paroxetine were supplied by the National Institutes for Food and Drug Control (Beijing, China). PAXIL® CR was purchased from GlaxoSmithKline plc. (Brentford, UK) and applied as the reference formulation. Clozapine was obtained from Shandong Qilu Pharmaceuticals Co., Ltd. (Shandong, China). Methanol, acetonitrile and n-hexane were of chromatographic grade. All other chemicals used were of analytical grade. Beagle dogs (male, 4-year old) were purchased from Kangda Experimental Animal Technology Co., Ltd. (Guangdong, China). Dogs were maintained in separate cages and food and water were provided ad libitum.
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6

Formulation and evaluation of capecitabine tablets

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Capecitabine was obtained as a gift sample from Divi's Laboratories, Hyderabad, India. HPMC K4M, HPMC K15M and HPMC LVCR 100, partially pre gelatinized starch were obtained from Colorcon Ltd, India. Sodium bicarbonate and calcium carbonate were purchased from CDH Pvt Ltd, India. Micro crystalline cellulose was obtained from FMC biopolymer, USA and spray dried lactose with maize starch was obtained from Roquette Pharma, France. Dicalcium phosphate, talc and magnesium stearate were purchased from Loba Chemie, India. All other reagents of analytical grade and all the solvents in HPLC are of HPLC grade.
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7

Venlafaxine HCl Sustained-Release Formulation

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Venlafaxine HCl was generously gifted by Ranbaxy Labs. Ltd., Gurgaon, India. Various excipients like sodium alginate, HPMC (K4M, K15M, K100M) were provided by Colorcon, Goa, India, whereas CaCl2, carbopol 974P and chitosan provided by Evonik, Mumbai, India. While all other chemicals and reagents like sodium hydroxide, potassium dihydrogen phosphate used was of analytical reagent grade. Deionized distilled water was used throughout the experimental procedure.
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8

Isolation and Characterization of Crocin Markers

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Reference marker
compounds, trans-4-GG-crocin (also named as crocin-1), trans-3-Gg-crocin, trans-2-gg-crocin, and cis-4-GG-crocin, were isolated from the IIIM-141 extract
using semipreparative HPLC. These markers were used for standardization
of extracts by HPLC. Acetonitrile (SD Fine Chemicals), methanol (SD
Fine Chemicals), formic acid (Rankem), and ethanol were used in the
semipreparative isolation of markers by HPLC. Polyvinylpyrrolidone
(PVP)-K30 and ethyl cellulose 10 cps were procured from Sigma-Aldrich.
HPMC-K4M and HPMC-K15M were obtained as gift samples from Colorcon
Asia Pvt. Ltd. (Goa). Eudragit RS100 was received from Evonik Industries
as a gift sample. Empty hard gelatin capsules were obtained from Natural
Capsules Ltd. Bengaluru, India as a gift sample.
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9

Topical Ophthalmic Formulation Development

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AZM was procured ex gratis from Sun Pharma, Poanta Sahib,India. Carbopol 934P (Loba Chemicals, Mumbai), HPMC K4M (Colorcon), SBE-β-CD (Cydex Pharmaceuticals,), Edetate disodium (Loba Chemicals, Mumbai), Benzalkonium chloride (Ases chemicals works, Jodhpur), Citric acid (Ases chemicals works, Jodhpur), Disodium hydrogen phosphate (Loba Chemicals, Mumbai), Whatman's filter paper-41 (Whatmann Int. Ltd, England), Purified water (In house Laboratory) were used as it is for the experiments. Albino rabbits were obtained from the central animal house, Lachoo Memorial College of Science and Technology (Autonomous), Jodhpur, Rajasthan for the testing.
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10

Rizatriptan Benzoate Formulation Optimization

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Rizatriptan benzoate (Emcure Pharmaceuticals, Ahmedabad, India), Proloc 15 (Henkel Corporation, Rocky Hill, CT, USA), HPMC F4M, HPMC K4M and HPMC K100M (Colorcon Limited, Goa, India) were obtained as a gift. Tween 80, propylene glycol and polyethylene glycol 200 (PEG 200) were procured (Sigma Aldrich, St. Louis, MO, USA). All other chemicals and reagents utilized in this research were commercially obtained from local traders with the highest quality.
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