Tag Archives: Active Pharmaceutical Ingredient

The topic of plant extraction may be research topic and hence, all the topics or contents related to plant extraction cannot be included in this description

However, enough insight will be provided by categorizing the plant extraction into various groups that are easy to understand and absorb from a general view point. There will not be much technical information contained in this. However, many important points will be listed to know the very basics of plant extraction.

The plant extraction is broadly classified into the following seven categories for the purpose of this article:

  • Plant extraction – Oils
  • Plant extraction – From vegetables
  • Plant extraction – From fruits
  • Plant extraction – Dyes
  • Plant extraction – Herbal
  • Plant extraction – Cosmetic products and
  • Plant extraction – From roots

Even we use the plants and plant products directly in our day-to-day life, we do use the plant extraction in a limited quantity. For instance, one may not use all the above listed extraction altogether. One may use the oil extracts in large quantities in food industries, whereas the dye extracts may be widely used in garment or some chemical industry. Herbal, root and medicinal extracts are mainly used in healthcare or medical fields. Fruits and vegetables extracts play a vital role sometimes in helping to nourish the body parts, internal or external.

The plant products such as leaves, vegetables or fruits are generally taken in large quantities. However, plant extraction are taken in proportions when compared to the actual fruit or vegetable. The dictionary definition for extract is ‘to remove from a larger whole’. It can also be referred to as essence or concentrate. The extract is a concentrated portion from the large vegetable mass, such as the plant extraction of sugar cane juice from the sugar cane plant, leaving the fodder aside and the juice in a glass. The juice is referred here as the extract. Let us now explore the different types of plant extraction.

 

An Example for API manufacturing

There are several types of API manufacturing in present days

Almost every antidote which is biologically synthesized contains Active Pharmaceutical Ingredient in it. There are used in almost every field of pharmacy and especially in herbal treatment. One such example is Gemfibrozil API manufacturing which is a drug used for lowering lipid levels. Lipids are fat layers present under the skin which determines the amount of cholesterol present in our body. People who are obese are prescribed to take this API. It belongs to the drug family of fibrates and this API is manufactured.

This API is an activator of Peroxisome  proliferator-activated receptor – alpha (PPARA) which is a nuclear receptor related directly to the synthesis of carbohydrates and fat. It is proven to be effective in adipose tissue differentiation.

When taken as recommended it results in the reduction of triglyceride levels and very low lipoprotein (VLDL) and a reduction of a less magnitude of LDL levels. It results in the level increase of high-density lipoprotein (HDL) levels. Normal medication dosage of gemfibrozil is 600 mg a short while after breakfast.

Some precautions while taking these drugs are given here. Those who are suffering from kidney failure must not take this.

People with diabetes must also avoid this because intake of these drugs may lead to a rise in insulin levels. This drug may lead to side effects like gallstones, hypokalemia and even cancer also. So these drugs are better to be avoided in case of a longer medication situation.    

Like Gemfibrozil, there are several kinds of API manufacturing like Venlafaxine which is used as an anti-depressant, Carbidopa API manufacturing which is used for the treatment of Parkinson’s disease which affects the key areas of the brain, Diltiazem API which is used for cardiovascular diseases and many more. These make the pharmaceutical industry go leaps and bounds in curing millions of people.   

Stability testing of Active pharmaceutical ingredient

The purpose of stability testing is to deliver indication of how the quality of an Active pharmaceutical ingredient fluctuates with time under the effect of a multiple environmental factors such as temperature, humidity and light

The stability program also contains the study of product-related factors that effects its quality, such as interaction of Active pharmaceutical ingredient with excipients, container closure systems and packaging materials

Test Tube Erlenmeyer Flask Chemistry Laboratory

Various stability testing procedures:

  • Stress testing of the Active pharmaceutical ingredient can assist to recognize the probable breakdown of products, that consequently aids in establishing the degradation pathways and the fundamental stability of compounds and prove the  power of the analytical procedures used for indicating stability.
  • Container closure system :The steadiness studies has to be  done on the Active pharmaceutical ingredient packaged in a container closing system that  triggers the packaging proposed for storage and distribution
  • Specification: The study of stability has to contain testing of those characteristics of the Active pharmaceutical ingredient that are vulnerable to transformation during storage and possibly effect the quality, safety and efficacy. The testing should cover, physical, chemical, biological and microbiological attributes
  • Testing frequency: The frequency of testing should be adequate to establish the stability attribute of the Active pharmaceutical ingredient. For Active pharmaceutical ingredient with an expected repeated test stage or shelf life of at least 12 months,  the regularity of trying long-term storage state must  usually be once in 3 months in the first year, and then every 6 months in the second year and then once a year for the remaining life term
  • Storage conditions: Conventionally an Active pharmaceutical ingredient should be examined under storage conditions that test its heat stability and moisture sensitivity as well. The length of study and the condition in which storage is done is generally enough to cover shipment and storage.

General Questions related to Active Pharmaceutical Ingredients

What is an active Pharmaceutical Ingredients? Difference between an active ingredient, a bulk process intermediate and an active pharmaceutical ingredient?

Active substances are the elements in tablets that are accountable for the good health lived by clients. The active ingredient in a drug is known as the API (active Pharmaceutical Ingredients). For instance, an API is the acetaminophen in an ache comfort pill. The energetic aspect in a organic medicine is known as a bulk system intermediate (bpi). BPI is the insulin in the insulin cartridge used by diabetes patients.

Why regulate active Pharmaceutical Ingredients?

The great of energetic substances in a drug has an instantaneous impact on the safety and efficacy of that drug. Poorly manufactured and contaminated active components were related to poor health consequences, inclusive of demise.  This is why maximum international locations around the arena are actually regulating lively ingredients.

Regulating active elements in Canada will assist growth the first-rate and safety of medicine for consumers, will fortify the pharmaceutical drug delivery device in Canada, and could bring Canada into line with its worldwide regulatory companions.

When will the modified Drug and Food policy come into effect?

The meals and drug regulations (rules) were amended by way of extending the necessities of established order licensing and appropriate manufacturing practices to the producing and importation of energetic pharmaceutical ingredients. The amended regulations were posted in   part ii of the Canada gazette on May additionally 8, 2013, and came into force on November 8, 2013.

This is the first study to mix the method of dehydration scattering functions from one active pharmaceutical Ingredients crystal and the consequences will in addition improve the know-how, components and choice of active pharmaceutical ingredients utilized in drug manufacture these days. The organization at BMS anticipates that those same facts interpretation strategies might be beneficial to other researchers and that extra consumer friendly modeling software may be made available in the destiny.

Fermentation- How to ferment vegetables

Based on the numerous benefits that arise from consuming fermented foods, vegetable fermenting is something that you can consider taking up from the comfort of your home. The process is simple and you can use vegetables from your garden or from your local market to make them last longer.

Preparation

You can ferment them whole, chop or shred them all based on your desired end product. It involves salting which can be done in two ways.You can salt them directly by sprinkling salt on them and pounding them until they produce juice that covers them well in the fermentation vessel or you could also dip them in salty water, brine, and ensure that they are completely covered.

Once salted, pack them in the jars and ensure they are fully submerged in water or the juice. Where they don’t produce enough juice, add filtered water.

The process

Fermentation is a process that takes time and in most cases,it begins within a couple of days and continues for much longer. This process is all dependent on the amount of salt used as well as the temperature of the fermentation location. More salt slows down the process whereas warmth speeds it up. The peak of fermentation depends on your taste and once satisfied, move them to your fridge where the process will continue but at much slower speed.As the days go by, the flavors will keep changing as the process continues.

Traditionally, fermentation was done to ensure the vegetables lasted through winter. Nowadays, itis done to improve the health benefits of the vegetables as well as help with weight loss. Fermented vegetables are not the easiest to take in in terms of taste but with time they grow on you and you may end up having them as a favorite.

Benefits of fermentation

All of us suffer from digestive problems at one point or another. The surest way to get rid of these problems is to create a balance between the good bacteria in the digestive tract and the disease causing bacteria.

Fermented foods provide the most effective solution as they are rich in lactic acid-producing bacteria. Fermentation of food involves taking them through a process called lactofermentation where the natural bacteria consume the sugar and starch in the food resulting in the formation of lactic acid.

This process not only makes the food taste sour but also preserves it and develops b-vitamins, probiotics, omega-3 fatty acids and other enzymes which are beneficial to human beings. Fermentation of food in the natural way also maintains its nutrients and makes it easily digestible. The probiotics arising as a result of the fermentation process could be the reason why consumption of fermented foods results in better digestion.

Benefits of food fermentation

There are a number of benefits that come from fermented foods:

Cost friendly- food can be fermented at home with ease and since fermented food lasts longer, you can buy it when it’s cheap and ferment for future use. Consumption of this food also takes away the need to use supplements further reducing your budget requirements.

Probiotics-consumption of fermented foods introduces good bacteria into the digestive tract which improves digestion and the bowel movements as well as one’s immunity.

Better absorption of nutrients-when the balance in the digestive system is restored, you will absorb the nutrients you take in better eliminating the need to take supplements.

Food preservation-normal food only lasts a few days in the fridge whereas fermented food can last for months and without losing the nutritional content.

Weight loss- balancing the bacteria in your gut is one of the things that will make you lose weight and feel better. Consumption of fermented foods is one sure way to achieve this.

Fermentation is mostly known for alcohol creation but its benefits in food are numerous and has recently gained popularity in the quest for weight loss.

Active pharmaceutical ingredient objectives and mission

Acitve pharmaceutical ingredient major manufacturers such as AstraZeneca, Merck and

GlaxoSmithKline are now slowly moving away from the multifunctional plants and are clearly opting at

specific sites for specific activities. In this way, the concerns are becoming serious as to how to have

centralized control and to function, when an API is manufactured in one country, by one company, and

the excipient is getting manufactured in another place by a different company. it is then packaged and

distributed making the route more difficult to control or monitor.

Spurring demand

The new technology in medicine is showing growth and there is a great demand worldwide for Acitve

pharmaceutical ingredient. Especially, there is an increases raw pharmaceutical ingredients importation

from the emerging markets. Countries such as China and India now meet the demand by supplying nearly

APIs of 40% and it is used in the US. It is expected that with the spurring demand, the same will double

to 80% in a decade’s time.

Objectives

 Acitve pharmaceutical ingredient membership comprises of companies from different

pharmaceutical sectors, but they are all involved in the APIs manufacture. This provides the

required base to develop and also to have a holistic, balanced view on the guidelines and API

related regulations.

 The focus of Acitve pharmaceutical ingredient is on the worldwide quality, regulatory matters

and good manufacturing practice and all these relate to Intermediates and APIs.

 APIC is now playing a vital role in regulatory environment improvement for the API

manufacturing industry, thus it is increasing patient safety and also benefiting the society as a

whole.

Mission

The aim is to promote the APIs use in medicinal products and also to ensure patient safety. Thus to

highlight the members interests to the experts so that there is influence in the regulatory environment and

the global GMP.

What are prequalified active pharmaceutical ingredients?

Prequalified active pharmaceutical ingredients are basically APIs that are part of the World

Health Organisation (WHO) prequalification program. These APIs have been assessed and

accepted in principle to be used in the manufacture of final pharmaceutical products to be

procured by the United Nation agencies.

For an active pharmaceutical ingredient to be prequalified by the World Health Organisation

(WHO), it must meet number qualifications. The prequalification process includes:-

– Inspection of the manufacturing site- WHO sends some of its officials to inspected the

manufacturing site of the active pharmaceutical ingredient in question. This is to make

the API is manufactured in standards that are acceptable worldwide.

– Assessment of data pertaining to the quality of the active pharmaceutical ingredient-

for an API to be prequalified by the World Health Organisation, it has to be of the best

quality possibly available. This is because the drugs will be used all over the world by

UN agencies. Poor quality of API could therefore lead to adverse effects spread across

the globe

TheWorld Health Organisation (WHO) later publishes a list of all the APIs it has qualified. The

list includes the following information:-

 The API’s World Health Organisation reference number

 The name of the API

 The applicant- this refers to the name of the company/ manufacturer who submitted the

API for prequalification

 The manufacturing site- the physical location of the manufacturer

 API specification number

 Information on how the prequalified active pharmaceutical ingredient is packaged.

 The shell life and storage conditions pertaining to the prequalified API

 The exact date on which the API was prequalified by WHO

 A conformation date of the World Health Organisation API prequalification document.

WHO only prequalifies the APIs that have meet its norms and standards and for which the

respective manufacturing sites are also of the World Health Organisation standards.

Fermentation Processes and its various types

The unit of fermentation in industrial microbiology is similar to a chemical plant that can be seen in a

chemical industry. Fermentation is a biological process and has certain requirements of sterility and use of

enzymic reactions. It does not include chemical reactions supported by catalysts. Fermentation is operated

at high pressure and temperature as well. The process of industrial fermentation is divided in two types

featuring various modifications and combinations, namely continuous and batch fermentations.

Continuous fermentation

During batch fermentation, the microorganisms’ growth confirms the characteristic curve of growth

following a lag phase in a loga-rithmic phase. It is terminated in the growth rate by progressive

decrements until it reaches the stationary phase and this happens owing to the limitation of essential

nutrients. However, the substrate in continuous fermentation is added at a fixed rate to the fermenter.

This helps in maintaining the organisms, besides the fermentation products are continuously taken out.

The arrangements and design for continuous fermentation is complex to some extent.

Batch fermentations

A fermenter tank is filled with raw materials mash to be fermented. The pH for microbial fermentation

and the temperature is adjusted and nutritive supplements are occasionally added to the mash prepared.

However, in a pure culture process, the mash is sterilized in steam. These pure culture inoculums are

added to the fermenter using a separate vessel. After a proper time, the fermenter contents are taken out

for processing. Thus, the fermenter is cleaned and the process is repeated. In this way, fermentation is

divided as a discontinuous process into batches.

Aerobic fermentations

Industrial processes are known as ‘fermentations’, but are carried by microorganisms under the aerobic

conditions. The modern fermentation in aerobic conditions are retained with submerged cultures in a

closed fermenter and these contents get aerated by forcing sterilized air and agitated with au impeller.

Anaerobic fermentations

Anaerobic fermentations need mild aeration for starting growth phase, and sufficient N agitation to enable

mixing and temperature maintenance.

The Basics Of Active Pharmaceutical Ingredient

Both personnel working at the active pharmaceutical ingredient plants, and the products being

manufactured, and the materials used in the production must be highly protected. Protection involves;

 Hiring highly qualified personnel and taking them through orientation training to increase their

competence

 Making sure that equipment and the production premises are effective and up to the set standards

 Labeling all materials, and containers correctly

 Having in place suitable transportation and storage facilities

 Keeping well-updated records

Enforcement methods of protection

Manufacturers must install efficient air filters to help put contamination and cross contamination at bay.

Air filters installed are dependent on ambient and return air quality. There are different protection levels

for divergent filters. It is the active pharmaceutical ingredient manufacturer’s duty to exercise measures

that will help counter contamination through the unfiltered air.

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Cross contamination happens when dust or components of one product get in touch with another. With

the correct pressure cascade and air movement procedures followed, this can be avoided. The correct

pressure cascades should be used when manufacturing products with a high potent rating. In general, it is

important to ensure the right pressure cascades are installed according to the product being manufactured.

Different active pharmaceutical ingredient products have got different pressure cascade specifications.

There is a need to put in place special attention to the structural aspect of buildings. Active

pharmaceutical ingredient factories must be able to house different pressure cascade designs.

Consideration must also be put on the general set up of the building so as to bring down ingression and

egression of air.

Since the manufacturing process of APIs can cause more harm than good if special procedures are not put

in place to protect it. Measures must be put in place to control the emission of dust and vapor into the

environment.