Reworking Potential of Polyvinylpyrrolidone K-25 as a Binder in The Production of Paracetamol Tablets

Abstract

Binding agents play an important role in maintaining the bond between active and additional ingredients in tablets, especially when subjected to repeated compression. One commonly used binder is polyvinylpyrrolidone (PVP) K-25. However, issues often arise regarding the binder’s potential when undergoing multiple compressions. This research, hence, aims to determine the reworking potential of PVP K-25 with different concentration levels as a binder, focusing on the physical properties of the mixtures and the resulting paracetamol tablets. The study follows a pure experimental design with a two-way completely randomized research design. Tablets were compressed and subsequently crashed again twice. Various tests, including flow properties and compressibility for the mixtures, as well as compatibility, hardness, friability, and disintegration time for the tablets, were conducted to assess their physical properties. The obtained data were subjected to statistical analysis, starting with the Shapiro-Wilk normality test, followed by Kruskal Wallis and Post-Hoc Mann-Whitney tests. The research findings indicate that PVP K-25 can maintain its potential as a binder, as evidenced by the physical properties of both the mixtures and the resulting paracetamol tablets.

Introduction

Tablets have undergone significant advancements in formulation and offer several advantages. One of the key benefits is their practicality compared to other pharmaceutical forms such as suppositories or injections. Tablets are solid preparations containing a single dose of one or more active ingredients. They consist not only of active ingredients but also of additional components that help maintain the effectiveness of these ingredients during production and use. Common ingredients added to tablet formulations include diluents, disintegrants, binders, lubricants, and glidants.1 Paracetamol is an analgesic and antipyretic.2 However, paracetamol has poor flow and compressibility properties, which necessitate forming it into granules using the granulation method.3 Due to paracetamol’s resistance to heat and humidity, wet granulation is the most suitable method.

Wet granulation involves processing a mixture of active substances and excipients into larger particles by adding a binding fluid, forming a moist and easily granulated mass.4 A binder compatible with the active substance’s physical properties and other excipients must ensure the resulting tablet is compact. Polyvinylpyrrolidone (PVP) K-25 is commonly used as a binder in tablets produced using the wet granulation method. PVP K-25 can also enhance the dissolution of substances that are otherwise difficult to separate from the tablet dosage form. In general, PVP K-25 is added at 0.5–5% w/w in tablet formulations.5

In the pharmaceutical industry, the tablet compression process is sometimes repeated due to various factors, such as the failure of the tablet to meet predetermined requirements. To avoid material losses, industries often recompress the tablets, especially for highvalue materials. During the recompression process, particularly in the wet granulation method, the binder plays a crucial role in reuniting the crushed tablets into granules and compressing them back into intact tablets. The binder helps bind granule particles together, preventing the tablets from cracking or breaking easily.6 This process of crushing and re-compression is known as “reworking potential.”

Although reworking potential can be beneficial, it may alter the mixture and physical properties of the tablet. Research7 found that reworking potential significantly affects the mixture (flow rate, compressibility, and compatibility) and the physical properties of paracetamol tablets (tablet hardness, friability, and disintegration time)7. On the other hand, Gamlen’s research8 suggests that reworking potential does not affect tablet hardness.

Therefore, further research is needed on the impact of binders after repeated compression. The purpose of this study is to determine the reworking potential of PVP K-25 at different concentration levels as a binder, with a focus on the physical properties of the mixture (flow properties and compressibility) and the physical properties of paracetamol tablets (compatibility, hardness, friability, and disintegration time). The mixture in this context refers to a blend of lubricated granules.

Download the full article as PDF here Reworking Potential of Polyvinylpyrrolidone K-25 as a Binder in The Production of Paracetamol Tablets

or read it here

Materials

Paracetamol pharmaceutical grade (Anqiu Lu’an Pharmaceutical Batch No. 2150096), paracetamol standard USP grade, PVP K25 pharmaceutical grade (Kollidon® 25 Lot No. 01082147G0), croscarmellose sodium pharmaceutical grade (Primellose® Batch No. 108NS4T), talc pharmaceutical grade (Pingdu Talc Mine Co., LTD Shandong Batch No. YF1-022-201 24 MT), magnesium stearate pharmaceutical grade (Eur Phar Batch No. MGSV1230092), and lactose monohydrate pharmaceutical grade (Brataco Batch No. J 017/23 (23208277)) were used.

Agatha Budi Susiana Lestari, Lie Dofi Ananda Madelin Okana, Journal of Fundamental and Applied Pharmaceutical Science, Reworking Potential of Polyvinylpyrrolidone K-25 as a Binder in The Production of Paracetamol Tablets, Published 2025-08-26, Issue Vol. 6 No. 1 (2025): August