Spherical agglomeration, also known as balling, is a pelletization technique whereby powders are transformed into spherical particles through the addition of a suitable amount of liquid or exposure to elevated temperatures, facilitated by a continuous rolling or tumbling motion. Spherical agglomeration can be classified into two categories: Liquid induced agglomeration and Melt induced agglomeration. Liquid-induced … Read more
This method entails the application of successive layers of a solution and/or suspension containing drug substances and binders onto starter seeds, which can consist of inert materials or crystals of granules of the same drug. In this method, drug particles and other components are either dissolved or suspended in the application medium. The droplets strike … Read more
This method entails the application of successive layers of drug powder, along with excipients or both, onto pre-formed nuclei or cores using a binding liquid. During the powder layering process, the binding solution and finely milled powder are introduced simultaneously to a bed of starter seeds at a predetermined controlled rate. In the initial phases, … Read more
Pelletization is a process of agglomeration that transforms a fine powder mixture of drug(s) and excipients into small, free-flowing, spherical entities known as ‘pellets’. The method is essential for creating pellets that are uniform in size, possess a high drug loading capacity, and also mitigate segregation and dust. Rationale for Pelletization The controlled release application … Read more
Dr. Dale Wurster at the University of Wisconsin pioneered the Wurster process in the 1950s. In recent years, this process has gained traction within the Indian pharmaceutical industry due to the burgeoning opportunities in the generic market. Almost all leading companies are now exploring particle coating using the Wurster method. Furthermore, this process can be … Read more
A capsule is characterized as a solid dosage form that contains medicinal agents in the form of ‘powder’, ‘pellets’, ‘liquid pastes’, or ‘tablets’ enclosed within a hard or soft soluble shell. The shells are typically made from gelatine. Capsules are considered an oral drug delivery system that offers a dosage form that is nearly tasteless … Read more
The dissolution specification is defined by the amount (Q) of active substance that dissolves within a designated time frame, represented as a percentage of the content indicated on the product label. According to the Indian Pharmacopoeia, the dissolution specification is articulated in terms of the amount (D) of active substance that dissolves in a specified … Read more
According to the solubility and permeability of drugs, the following Biopharmaceutics Classification System (BCS) is suggested in the literature (Amidon 1995) This classification serves as a foundation for establishing in vitro dissolution specifications and also aids in predicting the probability of achieving a successful in vivo-in vitro correlation (IVIVC). The solubility of a drug is … Read more
A tablet’s strength has a significant impact on its marketing, transportation and dissolution. The mechanical strength of tablet or granules can be determined by its hardness and through friability test. A clear synthetic polymer drum with polished internal surfaces that is not susceptible to static buildup shouldbe used; it should have an internal diameter of 283 to 291 mm and a depth of 36 to 40 mm. The drum has a detachable side. A curving projection that runs from the center of the drum to the outside wall and has an inside radius of 75.5 to 85.5 mm tumbles the tablets with each rotation of the drum. A device that revolves at 25 ±1 rpm has the drum fixed to its horizontal axis. As a result, the tablets slide or roll during every rotation, landing on the drum wall or one another. Friability test procedure and Acceptance Criteria
Formulation of the coating solution: Adequate preparation of the coating solution is essential for achieving an effective coating within a reasonable timeframe. This solution is prepared in S S vessels equipped with a stirrer. Various techniques are beneficial in facilitating the prompt formulation of coating solutions: Dispersion in hot water: The coating materials remain insoluble … Read more
