Active Pharmaceutical Ingredient (API) Process Development

What are Active Pharmaceutical Ingredients (APIs)

The active elements in a pharmaceutical medicine that have the desired impact on the body to treat a condition are known as Active Pharmaceutical Ingredients (APIs). In the API Process Development, chemical substances are processed to create APIs. Acetaminophen, which is found in painkiller tablets, is an illustration of an API. Bulk process intermediate refers to the biological drug's active component (BPI). The insulin included in an insulin pen cartridge used by diabetics is an illustration of a BPI.

In general, the API Process Development and Production involve a number of processing processes, including reaction, crystallization, separation and purification, filter cake washing, solvent swapping, and solvent exchange.

Types of Active Pharmaceutical Ingredients (APIs)

APIs can be broadly classified into two categories: natural and synthetic. Synthetic APIs are further split into innovative and generic synthetic APIs based on the synthesis process.

A large amount of drug products in the pharmaceutical industry is made up of small molecules, or synthetic chemical APIs.

Natural APIs are used to make biologics, which are becoming more and more popular pharmaceuticals on the market. There are currently much fewer biologics accessible than small molecule medicines, despite the increased demand.

APIs are divided into soluble and insoluble categories based on their solubility.

Barriers in Active Pharmaceutical Ingredient (API) Process Development

Only 10% of new drug candidates succeed in reaching the market because commercializing a drug is not an easy process. There are a few barriers and unique challenges in API Process Development. The most frequent cause of failure is a lack of clinical efficacy, but another frequent problem is the creation of subpar formulations with poor drug-like qualities.

Here is where a drug's success can be made or broken by the API Process Development stage, which comes right after the work on drug discovery and early formulation. A group of lab technicians and scientists must decide how to create the active pharmaceutical ingredient (API) into an appropriate dose form for pilot production during this stage. The same method should subsequently be scaled up for commercial manufacturing if clinical studies are successful.

The choice of pharmaceutical manufacturing machinery for blending, extrusion, drying, milling, and micronization constitutes a significant portion of the process development of drug products. Establishing a precise strategy in the API Process Development by utilizing those systems to create a final drug product with the specified physical characteristics and quality features is just as crucial as installing the appropriate processing, development, and material handling technologies.

Tablets and capsules have been recognized as one of the most frequently produced oral dosage forms since the development of modern medications. They still are believed to account for almost two thirds of all medications that are prescribed and purchased without a prescription today. The special difficulties that the API Process Development presents are undoubtedly not unfamiliar or new to the pharmaceutical sector.

During specific API Process Development stages, the primary step in powder processing is milling, which involves reducing large particles to smaller ones for a range of processability, bioavailability, reactivity, and safety-related considerations. The drug's efficacy and its capacity to deliver the API to the targeted site in the body at the right pace and concentration are both influenced by particle size distribution (PSD). This is an exact science since the ultimate result will be greatly impacted by the production of too-fine or not-fine-enough powder.

Overheating, oxidation, powder bridging, sieve obstructions, and poor flowability problems are frequently experienced during milling and material handling. In most cases, the necessary physical qualities of the formulation can be obtained by adjusting a wide range of process parameters.

During the API Process Development phase, safety and risk management should also be carefully considered. Low minimum ignition energy (MIE) products could cause an explosion, necessitating the deployment of anti-explosion procedures. Some procedures might need confinement due to the toxicity of several active components used in the production of pharmaceuticals in order to prevent operator exposure to dangerous, powerful compounds.

To reduce the timeline of API Process Development, the process must be effective, reliable, and cost-efficient in addition to meeting standards for operator and product safety. Companies can use automation to assist them reach these objectives, although doing so increases process development complexity.

Regulating Active Pharmaceutical Ingredients (APIs)

The safety and effectiveness of drug products are directly impacted by the caliber of its active components and are ensured through process optimization. In numerous cases over the past few decades, subpar API Process Development and production as well as tainted active components have been linked to adverse health effects, including death. Because of this, regulatory procedures and approvals of active ingredients have been made more stringent in most of the countries across the globe.

The regulation of active components will strengthen the pharmaceutical drug supply chain, improve the quality and safety of medications for patients, and align a company with global regulatory practices.

Active pharmaceutical ingredients (APIs) are prequalified by an independent process that determines those that are high-quality and produced in accordance with WHO Good Manufacturing Practices (GMP). Prequalification of a Finished Pharmaceutical Product (FPP) for which prequalification is sought is significantly easier if an API that has already received prequalification is employed in its production.