MedicalPharmaceutical Formulations – An Overview

January 24, 2023by Bhawins0

H1- Introduction to Pharmaceutical Formulations


Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form. Pharmaceutical formulation is the multistep process where the active drug is mixed with all other components by considering the factors of particle size, polymorphism, pH, and solubility and becomes the final beneficial medicinal product. Benefits and constraints of the active pharmaceutical ingredients (APIs), valuable excipients, associated interactions, and manufacturing procedure are the four basic components for a successful pharmaceutical formulation. The formulation often functions in a way that includes different dosage forms. The dosage form is the pharmaceutical drug product as marketed for use with a specific mixture of active ingredients and inactive components. It has to be a particular configuration(capsule shell, for example) and distributed into a particular dose. Pharmaceutical formulation is the formation of a pharmaceutical product, including a drug’s chemical properties, formulation, and details of the treatment protocol to be implemented in the clinical application. There are currently tens of thousands of medication formulations available on the market for clinicians to prescribe and for patients to utilize.  Each of these pharmaceutical formulations has had a significant amount of time and money put into the production to the combination of medications to understand how they work and to test their efficacy.  It is known that developed drugs interact with numerous proteins within the human body, and only a handful of these proteins are the targets of the medications developed; this leaves rooms for the future development of additional drugs to target the remaining proteins in the human body. 

The development of pharmaceutical formulations (internal back link) is currently dependent on trial and error methods. Trial and error methods help predict optimal formulations. This process is time-consuming and expensive and involves a significant amount of labor to develop and monitor. There is pressure on the pharmaceutical industry to decrease the cost of healthcare and the number of new active pharmaceutical ingredients (APIs). To combat this, determining the desired formulations is necessary for the industry to determine efficient ways to develop drugs. 

API must be safe and efficacious, but the excipients, primary packaging materials, devices need to be safe as well.  Before starting human trials, formulations must successfully pass various studies of preclinical (animal) trials for ensuring safety and efficacy. Besides the knowledge of different formulation parameters, it is significant to understand the toxicology, pharmacokinetics, chemical, and physical characterization. When minimum physicochemical characterization is over, then the work for developing formulation begins 


H2- Clinical Significance

The clinical relevance of pharmaceutical formulation (internal back link)   is that they have a significant impact on one’s quality of life, disease outcomes, and adherence to the treatment protocol. Additionally, the effectiveness of a pharmaceutical treatment depends on a multitude of factors, including a medication’s chemical properties, formulation, and mode of administration. The drug must be stable and acceptable to the patient, and this is the primary consideration when developing a preparation. The drug form varies by route of administration, and identical drugs can produce different results depending on the route of administration. 

Developed medications have maximized efficiency when used properly. More complex regimens show decreased patient compliance; thus, it is necessary to develop a low complexity regimen for maximum effectiveness.


H2- Bhawins is dedicated in providing quality pharmaceutical formulations.

1) H3- Spheronization

Spheronization is the process where extrudates (the output from an extruder) are shaped into small rounded or spherical granules. In practice, these usually vary in size from 0.4 to about 3.0 mm. The use of these spheroids can be relevant for a wide variety of industries. Spheronization provides an efficient method of producing uniform discrete particles of various sizes (size can be controlled, according to user needs between wide ranges of diameters). As an example, where spheres would allow better dispersion of ingredients is especially useful in the pharmaceutical, biotechnology (such as bone filler and regeneration) and nutraceutical industries. This allows for more accurate dosage measurements when filling capsules. In other industries such as neutraceutical supply, the capsules can be colored or coated allowing for easy identification, also dissolution and active material release properties can be controlled.

2) H3- Taste-Masking

Taste-masking techniques are applied to mask or overcome the bitter or unpleasant taste of active pharmaceutical ingredients/drugs to achieve patient acceptability and compliance. Oral administration of bitter or unpleasant tasting drugs is often the biggest barrier for patient groups, such as pediatrics and geriatrics. An unpleasant taste is the biggest barrier in the treatment of the pediatric population.

Unless the active ingredient is tasteless or does not have any unpleasant taste, taste-masking plays a key role in the success of a final solid oral dosage form


3) H3- Tabletting formulations


In the tablet-pressing process, it is important that all ingredients be fairly dry, powdered or granular, somewhat uniform in particle size and freely flowing. Mixed particle sized powder can segregate during manufacturing operations, which can result in tablets with poor drug or active pharmaceutical ingredient (API) content uniformity. Content uniformity ensures that the same API dose is delivered with each tablet. Most tablet formulations include excipients. Binder is added in the formulation to help hold the tablet together and give it strength e.g. lactose and hydroxypropylmethyl cellulose. Often, an ingredient is also needed to act as a disintegrate to aid tablet dispersion once swallowed releasing the API for absorption. Some amounts of lubricants are usually added as well. The most common of these is magnesium stearate. These help the tablets once pressed to be more easily ejected from the die.


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