Tag Archives: Active Pharmaceutical Ingredient

Peptides –use of APIs in pharmaceutical industry

The proteins and peptides accept basic parts in living body frameworks by controlling, planning as well as sorting out among cell limit and intra-cell correspondences.

From an invigorating perspective, these are further bio available than amino acids or proteins. Advance, peptides with less nuclear weight, less allergenic than neighbourhood proteins, illuminating why to drain protein for the most part utilized as a part of the arrangement of hypoallergenic infant supports. Additionally, as nature’s tool kit, the different physiological parts of peptides make them a fitting plausibility for the change of supportive masters. There is a wide arrangement of physiological activities affected by bioactive peptides and these bioactivities are managed by the sort, number, progression, and properties of amino acids display in the peptide. It justifies saying that while a couple of proteins, by and large, the beforehand said bioactivities are latent until proteins are hydrolysed to release physiologically dynamic peptides. Bioactive peptides are thusly sensible probability for some other time of pharmaceutical things, especially with the inspired stresses of side effects of little molecule medication and extended respect for better substances having prosperity staying away from or prosperity propelling properties.

peptides

Anticancer and Ant oxidative peptides

Antitumour and anticancer medications beat the amount of medicine hopefuls being made by pharmaceutical associations since human development is a champion among fundamental explanations behind death in the various made countries. Regardless of the way that oncology investigation is all around front line and has redesigned our cognizance of tumors, the accommodating open entryways are still limited owing to the inconvenience in particular centering of sickness cells leaving strong ones.

The significantly flimsy and responsive nature of free radicals and open oxygen species in the body realizes cell hurt and subsequently prompts contaminations, for instance, hypertension, cardiovascular, harm, diabetes mellitus, and neurodegenerative and flammable afflictions. Cancer prevention agents secure the body via looking free radicals and ROS moreover subduing lipid peroxidation reactions, in this way turning away oxidative damage.

peptides

Advantages of peptides usage

A peptide is described as no less than two invigorated amino acids. The Peptides are forerunners to proteins, which require no under 50 fortified amino acids, according to PeptideGuide.com. Despite playing out an extensive gathering of principal limits in the body, these peptides may have surrounded the explanation behind cell life on Earth, as showed by the article, “Peptides Might Hold ‘Missing Link’,” appropriated on May 3, 2010, in perspective of work by experts at Emory University.

Composed Research

Peptides are essential in inquisitive about and developing the new pharmaceutical industry. These peptides can be a trademark or falsely conveyed to give a patient help with domains like immune limit and hormone era. As showed by PeptideGuide, the peptides used as a piece of drugs are basic and unobtrusive to make, and fabricated peptides can emphatically influence the limit of trademark peptides starting now in the body.

Major Body Functions

Peptides happen ordinarily in every cell of every living thing. They have different limits, including the era of chemicals to help your body isolate outside substances and make against contamination operators for your protected structure and hormones which control everything ideal from improvement to sexual headway. Without peptides, the life would not be possible.

Diagnostics

Built peptides are now and again made not as a treatment rather as a characteristic instrument. Peptides react to the earth around them. Your pro can give you demonstrative peptides, those of which will change to a particular shading under an amplifying instrument and can reveal certain signs in your body. For example, a blue shading to red shading change can reflect the closeness of things like contaminations or toxic substances, as showed by the article, “Colorimetric Sensors for Biomedical Diagnostics and Drug Discovery,” appropriated in Drug Development Research in July of 2000. Illustrative peptides can similarly choose how these peptides that happen ordinarily in your cells are working.

 

Active Pharmaceutical Ingredient – Article 1 – Introduction To Active Ingredient

Origination – An active ingredient refers to the component of a pharmaceutical drug that is biologically active.

An active ingredient refers to the component of a pharmaceutical drug that is biologically active. It is often referred to as “Active Pharmaceutical Ingredient (API)” or “bulk active”. Many drugs may contain more than one API. Traditionally, the API were called “pharmacon” or “pharmakon” (derived from the Greek word “pharmacos”), which had the original meaning of “magic substance/drug”.

“Active constituent” is the term that is often used to refer to the active substance in a plant as the word “ingredient” marks the presence of a human agency while the word “natural products” means that the substances weren’t added by humans but occurred naturally.

A Medication’s Components

The Active Pharmaceutical Ingredient of a medicinal drug is the substance responsible for causing the effects of the drug itself.

Every drug has mainly two components, one is the API and the other, is the excipient. The API is responsible for causing the effects of the drug while the excipient is a liquid, such as mineral oil, that performs the task of delivering the drug to the system.

For example, the medication for headache, includes acetaminophen as active ingredient while the excipient in this case is the liquid in the drug.

Where are APIs made?

Since the beginning, pharmaceutical companies had been manufacturing APIs in their home country but since the past few years, they have started outsourcing the manufacturing process, to cut costs.

The largest of the pharmaceutical companies are located in Asia, specially in China and India, even though there are many in the U.S. and Europe too. Dr. Reddy is one of the companies which have outsourced their manufacturing work to cut costs on infrastructure, employees and expensive equipment.

drugs

Notably, the pharmaceutical company AstraZeneca Pharmaceuticals used to run multiple manufacturing units in the United States earlier. Now, they only have 15% of them left in the U.S. and are trying hard to outsource all of their manufacturing overseas.

Most Popular Active Pharmaceutical Ingredients

 

  • Acetaminophen (paracetamol)

 

The therapeutic purposes of the medicine: Used to treat mild flu, fever, and doubles as a pain killer for mild pain.

Contradictions: None, unless there’s an allergy to paracetamol itself.

Pregnancy: No complications.

Breastfeeding: No complications.

 

  • Rantidine

 

Therapeutic purposes of the medicine: It is used to treat sto

mach ulcers and can also prevent stomach ulcers by reducing the acid reflux that damages the coating of the body.

Contradictions:

  1. Allergy to the drug.
  2. The doctor should be consulted, and caution should be maintained when being consumed by a patient with liver or kidney impairment.

Pregnancy: The doctor should be consulted before the drug is consumed.

Breastfeeding: The pill is released with breast milk which can be harmful for the child.

Rantidine

 

  • Aripiprazole

 

Therapeutic purposes of the medicine: Primarily used to treat schizophrenia and bipolar disorders. Used as an add-on treatment in irritability in the case of autism, tic disorders and depressive disorders.

Side effects:

  • Not recommended to be used for patients of psychosis caused by dementia.
  • Neuropletic malignant syndrome, a movement disorder.
  • Not be to be used by patients who suffer from high blood pressure.
  • Not to be used by patients with diabetes.
    Aripiprazole

 

  • Amisulpride (Solian)

 

Therapeutic purposes of the medicine: Normally used to treat schizophrenia, is an antipsychotic medication.

Contradiction:

  • Extrapyramidal side effects (very common): including akathisia, parkinsonism, tremor, dystonia and others.
  • Hyperactivity, Nausea, Anxiety, Vomiting, Headache, Insomnia, Hypersalivation (common)

    Amisulpride

 

  • Benazepril (Novartis)

 

Therapeutic purposes of the medicine: In the treatment of heart attacks, congestive heart failure, hypertension and also in preventing the retinal and renal (kidney-related) complications of diabetes.

Contradictions:

  • Most common: Chronic cough (in about 20% of the treated patients) or headache, often developed after months of use.
  • Angioedema, elevation of potassium levels and anaphylaxis.

Benazepril

 

  • Bupropion (Wellbutrin/Zyban)

 

Therapeutic purposes of the medicine: Primarily used as an aid in smoke cessation, and as an antidepressant.

Contradictions:

  • Epileptic seizures, because of which the drug was taken off the shelves between 1986 to 1989. The risk of these seizures is mainly dependent on the dosage of the drug.

Regulations On APIs

Due to the fact that the active pharmaceutical ingredient is the main component of the pill, that causes the effects, poor manufacturing or compromise on the quality of the API can lead to seriously health problems, ailments, and even, death.

Since the pharmaceutical companies have started outsourcing their work, the concern has increased. The overseas countries which they are shipped to, have formed regulatory standards, regulations and oversight, to prevent any mistakes. Even the Food and Drug Administration body of the United States, inspect the APIs produced overseas before they hit the shelves.

The fact that manufacturing takes place overseas now, pharmaceutical companies are unable to go through every process of the manufacturing which has increased concerns. Even though the outsourcing, mainly to Asia, has helped companies cut costs on many things such as employees and equipment, and using that money to focus on Research & Development to find cures for more ailments, a compromise on the APIs can lead to severe problems.

To prevent these problems which may, in the worst case scenario, turn into an outbreak, the FDA of the United States organizes intense screenings to ensure, and maintain quality, and prevent any defects.

The violation of these standards can lead to serious problems for the companies, and in most of the cases, cause them severe loss, pushing them marginally back on their track of growth and development.

The Moral Question

The question is an ethical and moral one rather than one that’s about the strictness of the regulations.

The only way that APIs can be made safer for the consumers, is possible if the companies start keeping an oversight on the manufacturing process and conduct screening that can assure safety of the consumers.

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.