PROCESS ANALYTICAL TECHNOLOGY (PAT) IN PHARMACEUTICALS

 

Process Analytical Technology (PAT) is a modern technology which involves the use of step pharmaceutical processes to produce quality products. PAT is a technique by which pharmaceutical processes are developed, monitored, controlled and examined. This is to ensure that the right quality of raw materials for drug productions are used and the step by step manufacturing methods are maintained for the production of standard pharmaceuticals products. PAT ensures that properties of raw materials, production process, chemometric methods used in producing products are of generally acceptable standard. PAT is used to control online and important production processes parameters. The major use of PAT is to analyze and monitor product quality.

 

PAT is important in pharmaceutical industry to ensure that products are of good quality and not injurious to human health. This is accomplished by application of Critical Process Parameters (CPP) which are the important factors that affects the manufacturing processes of pharmaceutical products. The quality of these parameters is proportional to quality and standard of finished products. Traditional monitoring methods include the use of temperature, pressure, pH and other physical factors. PAT involves the use of in-line testing with infrared, Raman and physiochemical methods as a major means of controlling the manufacturing process.

 

Pharmaceutical products play an important role in the provision of quality health care services and in the health industry. These products are usually administered by general health care practitioners to treat, manage, monitor and control various sicknesses and diseases. There are lots of advancement in modern day pharmaceutical technology like the production of novel drugs and nanotechnology. This poses a challenge for pharmacists and other regulatory agencies to acquire a vast knowledge of the scientific, engineering and technological skills that arises from this advancement.


 

Factors That Influence The Process Analytical Technology Framework

 

The following are contributory factors to the production of quality products through effective quality control and monitoring of production processes.

 

1. Pharmacokinetic Characteristics Of The Drug

 

Pharmacokinetic characteristics of drugs explains how he drug reacts with the body after administration. It reveals the process by which the body absorbs it, its mode of distribution across the body, metabolism and excretion. These properties are determined by the channel of its administration and the dosage of the prescribed drug.

 

2. Route Of Administration

 

There are different ways by which a drug can be administered into the body. The most common is by direct intake through the mouth either as liquid or oral tablets. Other administrative ways which should be considered for quality monitoring and control are, by injection, through the nose, vagina, mouth, ear and many other routes.

 

3. Toxicological Characteristics

 

This is one of the essential factors that should be considered during manufacturing processes of drugs. Toxicological characteristics are the dangerous effects of the drug to the health of the consumer. It is a very critical parameter that must be taken into consideration when the process of administration and dosage of the product is to be formulated.

 

4. The Chemical, Physical and Biopharmaceutical Characteristics

 

The chemical composition of the pharmaceutical product must be described to determine its interaction with the various environmental conditions like temperature, humidity etc. The physical appearance of the drug determines the packaging technique, distribution approach and method of delivery. All the above-mentioned factors are controlled and monitored by process analytical technology, herby producing good and standard products while reducing toxicological effects to a minimum level till the drug expires.

 

Principles Of Process Analytical Technology In Pharmaceuticals

 

Production processes of pharmaceutical products comprises of various steps and techniques for the creation of quality and standard products. There are several techniques used to regulate and control characteristics of useful raw materials in the manufacturing of pharmaceutical drugs. With latest advancement in technology, there are lots of improvements in the examination of chemical properties and composition of drugs such as its cleanliness and identity.

Analytical Technology In Pharmaceuticals

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Some PAT strategies are:

 

At-line, in-line or online determination of quality production methods. Some instruments and strategies used are, near-infrared (NIR), vibrational acoustical and x-ray spectroscopy. Chemometric techniques like multi-variate statistical and pattern recognition method. Mechanisms for information monitoring and controlling production processes. However, pharmaceutical health officers, scientists and researchers are yet to comprehend the examination and analysis of some chemical compositions. This limitation may inhibit the usefulness of some raw materials being processed into products that may be harmful to the consumers.

 

PAT Tools

 

PAT tools are useful to combat challenges in comprehending some available raw materials. It may result to the generation of new ideas about the physical, chemical and biological characteristics of the raw materials and drugs produced. They help to increase the production process and quality of the products. PAT tools are also used to avoid the rejection of some product batches and also to minimize the production time. The common PAT tools are Spectroscopy (which includes near infra-red, Raman, infra-red) and Optical sensors such as turbidity probes or FBRM (Focused Beam Reflectance Measurement). Chemometrics is also an aspect of chemistry that uses both statistical and mathematical methods to obtain and examine information from PAT special tools.

 

Other tools are:

 

Process Analyzers

 

Process analyzers have been developed and improved to examine physical, chemical and biological properties of raw materials and finished products. They generate several informations that are useful for quality control, drawing inferences and making quality decisions.

 

Multivariate Tools

 

Multivariate tools are useful for obtaining data and informations, analyzing data and designing the PAT process. Knowledge acquired with these tools are very significant and useful for product design and production of quality products. The application of PAT in pharmaceuticals is a very essential technology for monitoring and control of product quality. PAT is an important factor in the advancement of pharmaceutical technology and the improvement of public health. PAT system encourages the pharmaceutical drug manufacturers to adopt new analytical techniques with the purpose of improving production processes.

 

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