Development of a Single In Vitro Dissolution Method for a Combination Trilayer Tablet Formulation of Clopidogrel and Pravastatin

Controlled-release (CR) pharmaceutical formulations offer several advantages over the conventional, immediate release dosage forms of the same drug, including reduced dosing frequency, decreased incidence and/or intensity of adverse effects, greater selectivity of pharmacological activity, reduced drug plasma fluctuation, and better compliance. After a drug product has been registered, and is already on market, minor changes in formulation might be needed. At the same time, the product has to remain effective and safe for patients that could be confirmed via plasma drug concentrations and pharmacokinetic characteristics. It is challenging to predict human absorption and pharmacokinetic characteristics of a drug based on the in vitro dissolution test and the animal pharmacokinetic data. Therefore, the objective of this study was to establish correlation of the pharmacokinetic parameters of carbamazepine (CBZ) CR tablet formulation between the rabbit and the human model, and to establish in vitro in vivo correlation (IVIVC) based on the predicted fractions of absorbed CBZ. Although differences in mean plasma concentration profiles were notified, the data concerning the predicted fraction of drug absorbed were almost superimposable. Accordingly, it can be concluded that rabbits may be representative as an in vivo model for predicting the pharmacokinetics of the CR formulation of CBZ in humans.

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Development and Validation of a Discriminating In Vitro Dissolution Method for a Poorly Soluble Drug, Olmesartan Medoxomil: Comparison Between Commercial Tablets

AAPS PharmSciTech ◽

10.1208/s12249-010-9421-0 ◽

2010 ◽

Vol 11 (2) ◽

pp. 637-644 ◽

Cited By ~ 9

Author(s):

Lisiane Bajerski ◽

Rochele Cassanta Rossi ◽

Carolina Lupi Dias ◽

Ana Maria Bergold ◽

Pedro Eduardo Fröehlich

Keyword(s):

Olmesartan Medoxomil ◽

In Vitro Dissolution ◽

Dissolution Method ◽

Poorly Soluble ◽

Poorly Soluble Drug ◽

Development And Validation

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Formulation and In-Vitro Evaluation of Enteric Coated Tablet Incorporating Rabeprazole

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v10i2-s.3953 ◽

2020 ◽

Vol 10 (2-s) ◽

pp. 50-57

Author(s):

Gautam D. Mehetre ◽

Rameshwar S. Cheke ◽

Vinayak N. Shrikhande

Keyword(s):

Drug Release ◽

Acid Resistance ◽

Tablet Formulation ◽

In Vitro Dissolution ◽

Content Uniformity ◽

In Vitro Evaluation ◽

Enteric Coated Tablet ◽

Coated Tablet ◽

Enteric Coated

The objective of the work is to try and assess the applicability and manufacturing possibilities to optimize an enteric coated tablet formulation containing Rabeprazole sodium as the drug aiming at the anti-acidity activity with desired drug release properties. Enteric coated tablet was chosen as dosage form being a cost-effective technology for pharmaceutical industry requiring fewer procedures. Before the implementation of the pharmaceutical technological aims, analysis of critical factors influencing the manufacture was carried out. Reproducible manufacturing processes are required to achieve suitability and tablets uniformity to achieve the uniform properties of tablets, which could influence experimental parameters. Rabeprazole in core content of tablet is blended with HPMC (different grades), xanthan gum, PVPK30, mannitol, crosspovidone, Sodium starch glycolate, Colloidal silicon dioxide to formulate the product. Prepared formulation was tested for weight and content uniformity, physical characteristics, in vitro dissolution behaviour, acid resistance and accelerated stability studies. All studies performed resulted and revealed for assurance of such enteric coated tablet formulation for drug Rabeprazole with optimum characteristics, concluding it as a promising approach to enhance drug release characteristics. Keywords: Rabeprazole, HPMC, enteric coated tablets, In Vitro evaluation.

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