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Tightly controlled particle size distributions in oral solid dosage forms are highly critical for drug production in the pharmaceutical industry. The particle size of drug distribution is a vital sign of the performance and quality of oral solid dosage forms. Once the research and formulation of a drug are complete, manufacturing these oral drugs requires pharmaceuticals to find the most effective method to have this new active pharmaceutical ingredient (API) converted into a suitable dosage form.
If you want to understand why particle size is so essential to oral dosage forms, this article will help gain a better perspective.The Flowability of an API and the ease of its handling of the API along with the excipients are the primary elements of drug production. Parameters that improve the efficacy, quality, and bioavailability (absorption) of such drugs are the particle uniformity, dissolution rate, and consistency of the contents. The impact of powders and particles on absorption rates and drug performance is constantly tested and assessed at multiple stages of drug development by manufacturers. Once they have the results and analysis of such impact in the last stage of development, manufacturers can specify the ideal particle size distribution to improve the drug product’s consistency and quality.
The formulation phase of a drug is highly critical for the development of medicines as it ensures that the active agent of the medication gets administered to the accurate location in the physiology, in the correct concentration, and at the appropriate absorption rate. But before we get into the nitty-gritty, let’s understand how exactly particle distribution works.
Particle size distribution refers to a metric stipulates that defines the total number of particles in oral dosage forms as per their size. It may seem like all the dimensions of particles present in a powder are identical, but it is not. Not every particle in a sample will be perfectly spherical; such particles (non-spherical) can be defined with the help of multiple length and width dimensions.These characterizations of non-spherical particles give manufacturers greater accuracy at the expense of increased measuring complexity.
Hence, the majority of the methods use the assumption of every particle being a sphere. The reported dimension is described with the diameter of an equivalent sphere.A histogram or frequency diagram is created to represent the particle size distribution range; where the x-axis represents the particle size and the y-axis denotes the frequency occurrence of particles of a particular size.The width of the distribution curve is considered the most important in the pharmaceutical industry.
During the formulation and production of pharmaceutical drugs, demarcating the particle size distribution and ensuring consistency is highly important. This will make sure that the bioavailability of the APIs remains consistent. Additionally, off-specification particle sizes can lead to slowed production and diminish yields that impact the manufacturer’s ROI.A decline in inflow or inconsistency while discharging powdered drugs to a tablet press can lead to quality concerns. These may look like discrepancies in the weight and content uniformity of each tablet in the compression phase.Particle size is also linked to the compressibility of a formulated powder.
Extremely fine particle sizes cannot lock well together. Smaller particles in a fine powder require the manufacturer to insert additional measures to keep up the quality and content consistency due to the challenge of adhesion with finer particles.While the compression of tablets with very fine particles takes place, another stage called pre-compression is required. Here, the operator deploys an initial lighter pressure in compression prior to the actual stage of compression. Without pre-compression, a manufacturer will face problems like lamination or capping. Capping occurs when the lower or upper portion of the tablet splits horizontally when the press ejects it.
The production of small dusty particles called ‘fines’ in production increases the operation costs since they are wasted parts of the particles that have no use or reuse. Hence, it is necessary to ensure that the particle distribution while creating the drug formulation powder is kept to the optimal levels, ensuring maximum uniformity.
In conclusion, controlling the size of particles in oral solid dosage forms will not just enhance the workflow production to be more effective, but also lead to superior quality oral drugs that check all the criteria like dissolution, bioavailability, and validated effectiveness critical for production.
ZIM Labs is an innovative drug delivery solution provider focusing on improving patient convenience and adherence to drug intake. We offer a range of technology-based drug delivery solutions and non-infringing proprietary manufacturing processes for the production and supply of innovative and differentiated generic pharmaceutical products to our customers globally.
ZIM provides its customers with a comprehensive range of value-added solid dosage differentiated generic products in semi-finished and finished categories/formulations. These include granules, pellets (sustained, modified, extended-release), taste-masked powders, suspensions, tablets, capsules, and its recently developed Oral Thin Films (OTF).
