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Sunday, May 3, 2020 | History

2 edition of Bioequivalence of sustained release theophylline formulations. found in the catalog.

Bioequivalence of sustained release theophylline formulations.

Ronald Purkiss

Bioequivalence of sustained release theophylline formulations.

by Ronald Purkiss

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  • 28 Currently reading

Published by Aston University. Department of Pharmaceutical Sciences in Birmingham .
Written in English


Edition Notes

Thesis (PhD) - Aston University, 1986.

ID Numbers
Open LibraryOL13775656M

Bioequivalence study of two sustained-release theophylline formulations in the dog. By MENGOZZI G, INTORRE L, BERTINI S and SOLDANI G. Year: OAI identifier: oai: Provided by: Archivio della Ricerca - Università di Pisa. Download PDF. Formulation development of sustained release Theophylline pellets by drug layering method 3 rd World Congress Bioavailability & Bioequivalence March , Marriott Hotel & Convention Centre, Hyderabad, India. M. Bhanu Prakash Posters: J Bioequiv Availab. Abstract.

This study evaluated the relative bioavailability of a sustained-release capsule of theophylline, an elixir of theophylline, and a sustained-release tablet of aminophylline. Twelve healthy, nonsmoking, adult male subjects received nine doses of each of the three products in a crossover study conducted over a ten-day period. Each dosage form contained approximately mg of theophylline and Cited by: 7.   Five new experimental sustained-release (SR) formulations of theophylline, T-l, T-l-A, T-2, TA, and TE, in a matrix tablet form with a protein were developed. The in vitro release of theophylline from these novel experimental formulations and two commercial (Theotrim and Theo-Dur) SR formulations, was studied for 2 hr immersed in simulated gastric fluid TS, followed by an Cited by:

Author(s): C. J Shishoo, S. S Savale As part of ongoing programme on the development of a sustained release (SR) formulation of theophylline ( mg capsule) and determination of its bioavailability, a specific, sensitive and simple HPLC method has been developed for the estimation of lower mg levels of theophylline in plasma. 8-Chlorotheophylline was used as an internal : C. J Shishoo, S. S Savale. Bioequivalence of a new sustained-release formulation of sodium valproate, valproate modified-release granules, compared with existing sustained-release formulations after once- or twice-daily administration. Pharmacotherapy. ; 25(1) (ISSN: ) Dulac O; Alvarez JC.


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Bioequivalence of sustained release theophylline formulations by Ronald Purkiss Download PDF EPUB FB2

Formulation of Extended Release Theophylline Tablets Bioequivalence study. The 20 volunteer subjects, inthe study were, healthy males with an average age of32 years [range ] and an average body mass of kg (range 44 to 93 kg).

Their blood counts, liver function tests, creatinine and electrolytes were all normal. Regular ArticleComparative bioavailability of two sustained-release theophylline formulations in the dog.

Comparative bioavailability of two sustained-release theophylline formulations in the dog. Author links open overlay panel. GRAZIAMENGOZZIf1 LUIGIINTORRE SIMONEBERTINI MARIO GIORGI by: 6. With three sustained-release formulations it was predicted that fluctuations in serum theophylline concentrations between doses would decrease, as compared with uncoated tablets, to a clinically.

Bioequivalence Study of Sustained-Release Tablets [Saurabh, Rekha Singh, Rathore, Kamal Singh, Chauhan, Chetan Singh] on *FREE* shipping on qualifying offers. Bioequivalence Study of Sustained-Release TabletsAuthor: Rekha Singh Saurabh, Kamal Singh Rathore, Chetan Singh Chauhan.

Sustained-release formulations of theophylline as well as of other drugs are designed to effect a delayed but constant release of the active principle in the gastrointestinal tract, thus ensuring. Conclusions: None of the test products of theophylline were bioequivalent to the reference prod- uct.

The finding is of special significance since substitution of one brand of theophylline, a drug with a narrow therapeutic index, with another brand may result in sub-therapeutic response in patients. Abstract (summary): Objective: To determine the bioequivalence of two marketed test formulations (A, B) as compared to a reference formulation (R) of slow release theophylline in healthy volunteers.

Material and Methods: The study was conducted as an open label, balanced, randomized, three-treatment, three-period, three-sequence single-dose crossover study to determine the bioequivalence Cited by: 6.

Bioequivalence of a generic slow-release theophylline tablet in children ☆ ☆☆ ★ ★★ Author links open overlay panel Sukanya Kanthawatana MD, PhD a Richard C. Ahrens MD Michael McCubbin MD Edwin Bronsky MD Kathryn Blake PharmD Leslie Hendeles PharmD a Now at the Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, by: 1.

Biopharmaceutics of Modified Release Products and Challenging Drug Molecules Immediate Release and Modified Release Bioequivalence Requirements Vinod P.

Shah, Ph.D. Pharmaceutical Consultant (Formerly with US FDA) School of Pharmacy Faculty of Medicine The Chinese University of File Size: KB.

The policy stated in section applies to modified-release dosage forms, as defined in Report B of the Expert Advisory Committee: "Report on Bioavailability of Oral Dosage Formulations of Drugs used For Systemic Effects: Modified Release Dosage Formulations", except for ingredients that affect the release of drug from the formulation.

Eight healthy, nonsmoking volunteers (7 women, 1 man) between 23 and 41 years of age took a single dose ( mg) of two extended-release formulations of theophylline (form A, tablet; form B, capsule).Author: Helena M Payssé, Marta Vázquez, Pietro L Fagiolino. Thieme E-Books & E-Journals.

Summary. The objective of this study was to determine the bioequivalence of two theophylline (CAS ) sustained release formulations containing mg (Theophyllin retard Heumann, formulation A) and mg (formulation C) theophylline Cited by: 3. Regazzi MB, Rondanelli R, Vidale E, Cristiani D. Bioavaiability of sustained release theophylline formulations.

Int J Clin Pharmacol Ther Toxicol ; Gulati R, Roy V, Sachdeva A, Tripathi CD, Gupta U, Bapna JS. Bioequivalence of two brands of sustained release theophylline preparations.

J Asso Phys India ;   The effect of different intravenous infusions on the absolute bioavailability of theophylline from a sustained-release formulation has been investigated.

Oral administration of mg theophylline (2 capsules Euphylong ) was referenced to intravenous aminophylline infusions corresponding to mg theophylline over 8 h (63 mgh−1) in Study 1, and to mg theophylline Cited by: 7. Single dose study of the bioequivalence of two sustained-release theophylline formulations.

Contreras J(1), Pérez N, González R, Ontivero E, López M. Author information: (1)Department of Chemistry, National Center for Scientific Research, Havana, by: 3. This guideline focuses on recommendations for bioequivalence studies for immediate release formulations with systemic action.

It also sets the relevant criteria under which bioavailability studies need not be required (either waiver for additional strength, see sectiona specific type of. The objective of this study was to determine the bioequivalence of two theophylline (CAS ) sustained release formulations containing mg (Theophyllin retard Heumann, formulation A) and mg (formulation C) theophylline, respectively.

In addition, the relative bioavailability of the sustained release formulations in comparison to Cited by: 3. Abstract. 1 Plasma theophylline concentrations following administration of sustained-release (SR) theophylline tablets were determined in ten healthy volunteers using a dose of mg or mg 12 hourly.

2 The plasma theophylline levels during the first 12 h period confirmed the sustained-release formulation characteristics, with the plasma drug concentrations reaching a plateau for the last Cited by: 7. The bioequivalence of sustained release theophylline formulations, marketed in the United Kingdom, has been investigated in relation to the co-administration of food in both single dose and steady state volunteer studies.

The effect of food on pharmacokinetic. Formulations that give sustained release of drug, formulations with smaller disintegration time than dissolution rate and drugs used as replacement therapy also warrant bioavailability testing.

Drugs with steep dose response relationship i.e. drugs obeying zero order kinetics / mixed order elimination kinetics (e.g. warfarin, phenytoin. Four different brands of sustained‐release theophylline products of different strengths (nine formulations) were studied. The percentage of the dose released in 1 h in gastric fluid ranged from (mean ± SD) ± to ± %.

By 6 h, the percentage of the dose released ranged from ± to ± %.Cited by: Draft Guidance on Theophylline Theophylline in plasma. Bioequivalence based on (90% CI): Theophylline. proportional similarity of the formulations across all strengths, and (iii.Iraqi J Pharm Sci, Vol(2) Bioequivalence and pharmacokinetics of ER release pentoxifylline tablets 53 Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions Jaafar J.

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