Rationale for Selection of Dissolution Media: Three Case Studies

2014

The development of a discriminatory dissolution method for novel drug formulations has been a challenge to the pharmaceutical industry. Most of the times official dissolution method is not available for newly developed dosage forms. Parameters such as saturation solubility in different pH medium, dissolution behavior of formulations, influence of sink conditions, stability, and discriminatory effect of dissolution testing need to be studied for the selection of a proper dissolution medium for novel formulations. The present paper suggests a simple, scientific and systematic approach for development of an in vitro dissolution method for such novel formulations. In-house developed Metoprolol tartrate matrix tablet and Captopril sustained release beads were used as a model formulation. The developed methods were successfully applied for in vitro dissolution study of in-house developed novel formulations.

2012

International Journal For Multidisciplinary Research, 2024

Pharmacopoeias have approved the test of dissolution for evaluating the drug arrival of solid and semisolid measurement structures. Dissolution testing is mostly used in the biopharmaceutical description of pharmaceutical products as a tool to ensure consistent product quality and forecast drug bioavailability in vivo. Dissolve testing was first developed for solid orals, but its application was later expanded to include a variety of innovative dose forms. To characterize the in-vitro arrival of these measurement structures, new dissolving testing procedures must be developed due to the complexities involved in the medicine conveyance of unique dose structures. The article provides information on possible options for drug dissolving and discusses the continuous improvements in dissolution testing methodologies for both conventional and unique drug measuring structures

AAPS PharmSciTech, 2006

BioMed Research International, 2014

The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers. The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation.

The AAPS journal, 2017

The introduction of the biopharmaceutics drug classification system (Biopharmaceutics Classification System (BCS)), in 1995, provided a simple way to describe the biopharmaceutics behavior of a drug. Solubility and permeability are among the major parameters, which determine the fraction dose absorbed of a drug substance and consequently its chances to be bioavailable. The purpose of this review is to summarize the evolution of the media used for determining solubility and dissolution and how this can be used in modern drug development. Over the years, physiologically adapted media and buffers were introduced with the intention to better predict the in vivo solubility and dissolution of drug substances. Water, buffer solutions, compendial media, micellar solubilization media, and biorelevant media are reviewed. At this time point, there is no universal medium available which can be used to predict every drug substance's solubility or a drug product's in vivo dissolution beha...

2012

International Journal of pharma and Bio Sciences

This review aims to explore the past work done on the solubility enhancement of drugs using surfactants. Surfactants plays an important part in many routes of interest in both essential and practical science. The most vital function of surfactant is the formation of micelle in solution, which has specific significance in medicine because of their ability to improve the solubility of poorly water-soluble drugs, which need high doses to extend therapeutic plasma levels after oral administration. Poor water solubility is the major issue met with the formulation development of new chemical objects. A drug taken by the patient should present in the solution form at the site of absorption. The use of surfactants to elevate the dissolution of poorly soluble drugs has been employed. Surfactants can reduce surface tension and improve the dissolution of lipophilic drugs in the aqueous medium. When the levels of surfactants surpass their critical micelle concentration it deceives the drugs within the micelles. The authors collected sufficient literature on work done on the solubility enhancement of drugs using surfactants and presented in this paper. The authors conclude that this quick reference will be helpful for researchers in finding the literature on solubility enhancement of drugs using surfactants on a single click.

Journal of Drug Delivery and Therapeutics

In present days there is immense advancement in drug delivery despite novel drug delivery has become civilized as pharmaceutical scientists has worked hard over it. However the vocal pathway remnant the excellent pathway is for administration whereas the new drugs achieve the great patient compliance. The dissolution studies in NDDS have limit literature also and to still found locate inside the pharmacopeia. The dissolution studies is highly and commonly recommended for the solid dosage forms now a days it’s indeed enlarged to the other pharmaceutical formulations like suspensions, patches etc .The dissolution tactic is indeed an perfect tool such as maintaining batch-batch evaluation tests and also to analyze the drug release in vivo conditions. In sustained release the products that are obtained has several advantages in optimizing bio pharmaceutics and pharmacokinetics as compared to the conventional drug delivery systems. Keywords: Dissolution, sustained release, pharmacokinetics