Tag Archives: api

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.

Laser Diffraction PSD Method

This is one of the dominant techniques many industries use to measure particle size dissolution.

 

It involves the use of complex technology, standard and computerized data processing. Mie Theory of light scattering is always employed in Laser PSD method development to calculate the size of particles that are responsible for different light scattering patterns.

The operations of Laser Diffraction Technique

  1. The Presence of Laser Diode:  A laser diode is the device that produces a single but coherent beam of light.
  2. Light Detectors: they could be two or three. They help to collect the data of light intensity that scatter at different angles.
  3. Lenses: they are always in front of the particles. They focus the light rays that pass through the particles.

Using PSD method development, a laser beam of light will pass through the particles. All particles will scatter at different diffraction angles. Small particles scatter light at large angles and vice versa. Thus, the data of the particle size dissolution will be easy to calculate.Laser_diffraction_analysis_small_particle.

 

Benefits of Using Diffraction PSD Method.

 

As complex as PSD method development may look, it is very simple and fast to operate. It has an advantage over sieving technique because it can be used to measure liquids, sprays,powders and aerosols.

The use of special light detectors make it faster to collect the result or data of particles size distribution. Also, it produces high level of reproduction and precision. There is absence or lesser work hazard with its use. No industrial worker can intrude, interrupt nor disturb the process once it is  in progress.

Off-axis_parabolic_reflector

Disadvantages of Diffraction PSD Measurement

 

The resolution of Laser PSD method development diffraction varies with the size or amount of the particle. If there are mistakes in the refractive indices, there will be errors in the results.

To cap it all, it does not allow the measurement of  two or more particles with different optic properties. This is due to the fact that the use of laser is monochromatic in nature. That is, it only produces a beam of light.

 

Active Pharmaceutical Ingredient Manufacturing and Processing

There are several steps involved in the API manufacturing. All of these steps have to be co-ordinate carefully.

Not only that but it must be ensured that all of the API manufacturing equipments are used to their maximum efficiency. Hence maximum optimization is favored. All of this must be ensured without any compromise to the quality.

Care must be taken to ensure that the API manufacturing process takes place in a clean environment, avoid cross contamination of different APIs and maintain the requisite strength of the APIs.Molecule

The key to developing a good API lies in the raw materials chosen. Good laboratory conditions along with adherence to the health authority regulations are a must. The appropriate reactor must be chose along with a purification method that delivers the maximum throughput.

Roughly speaking the  various steps involved in API manufacturing are:

  • Selection of raw materials- the necessary raw materials of appropriate quantities must be selected. These comprise the starting materials.
  • Reactor- the raw materials are treated in a reactor under the optimal conditions to obtain the intermediate products.
  • Purification- now the intermediates are isolated and purified to obtain individual products. This involves a variety of purification techniques including, filtration, sedimentation, crystallization, and centrifugation and so on.
  • Standards- the products that are obtained as a result are checked for their strength. Each pharmaceutical company employs different standards to measure the strength of its API.
  • Packaging –finally the products are milled and packaged carefully.

The API manufactured is the incorporated or integrated with the transport agent, which is responsible for the drug’s delivery into our systems. We have to make sure that the API is agreeable with the inactive material chosen. Once more the drug is tested before distribution on a commercial scale.

Chemistry

Future of API manufacturin

Consistently, expansive pharmaceutical suppliers can eject anywhere in the range of 3000 to 5000 tons of unsafe industrial wastes eachIf someone ask any legitimate API producer how they might want to improve the procedure?, they’d likely say by speeding up the responses, or by minimizing expensive. The unexpectedlyanswer to that question is diminishing waste from API amalgamation would be to decrease the quantity of responses required to reject that outer particles Today there are in everywhere louder calls for API manufacturing to make big strides toward environmental friendliness – that is to say, to decrease the waste they create…,

In spite of howdistinctive is the objective might be, theyalways ends up with useless solutionof the same as less responses idea which meansnon-solution at all. Butglimmer of hope to solve this problem has been in horizon by putting forward brilliant idea environmentally friendly which is to discover effective solutions and impetuses that are more productive, as well as better for the planet.

scientist

What is the future of API manufacturing?  

By effortlessly search you will find many of known API manufacturing firms which aremoving far from multifunctional instils and rather than they choosing practice at in particular locales. Then, there will serious concerns on how come can they monitored? Especially after each of API made by one organization, in one nation, with the excipient made in another by an alternate organization, then merged and circulated to another organization inside and out makes this case somewhat difficult to becontrolled or over sighted.

The running development in new restorative innovations is inducing the APIsinterest overall today particularly with the expanded importation of crude pharmaceutical fixings from developing markets a recent consideredstudy concluded that nations like India and China, which now supply more than 40% of APIs utilized as a part of the U.S. will doubled that figure to an incredible 80% in only the following 10 years.

TAPI ‘In-house micronization’ for qualitative medicines

Who is the pharmaceutical company Tapi?

Who is the pharmaceutical company Tapi?A few specialists and administrators run TAPI’s biggest micronization office at our API fabricating site – Teva Tech in Israel. They regulate eight micronized and numerous factories of different sorts. We would say, taking care of micronization in-house has numerous advantages including:

  •    Less turnaround period.

Micronizing anproduct on location can dispose of downtime brought on by a conceivable generation or delivery delays from an outsider.

tapi

  •    Good quality control.

Since the product is made nearby, we can control the quality in each progression of the procedure, ensuring the micronized material is taken care of and put away appropriately, and guaranteeing our stringent measures are met.

  •    Flexibility to create tests.

In the event that a pharmaceutical producer is not certain what size molecule will work best in their dose structure, we can deliver tests with various molecule sizes for testing, then scale up when the client is prepared for creation.

  •    Industry aptitude.

TAPI has increased broad involvement in micronization throughout the years. Our R&D topic specialists bolster our learned nearby groups and guarantee they stay current on the most recent industry patterns and innovation.

molecula

TAPI Micronizationtechniques used:

Every now and then, clients have remarkable API needs that standard micronization strategies won’t address. A portion of the difficulties we’ve taken care of incorporates:

  • Obtaining to a great degree little particles with a limited molecule size dissemination (PSD) range and a high particular surface region with a restricted plane micronized
  • In each case, we team up intimately with the client to build up a particular arrangement that conveys aproduct that will work for them.
  • Unique micronized configuration to handle high electrostatic charged particles
  • Micronization of profoundly sticky material

Whether a medication product is a tablet, salve, breathed in solution or another measurements structure, molecule estimate frequently matters since it can assume a key part in how adequately prescriptions work. Much more imperative than the innovation is the information and experience of the master directing it. Ensure your API supplier has the ability to convey. At last, it is understanding prosperity which may profit.

What does synthetic organic chemistry do for us?

Chemistry and other branches of science are just very important for our life. Every advancement in technology and science will bring us a lot of benefits to us. Therefore, we should take a deeper look at the process of achievement for chemistry, and for that, we must learn what is synthetic organic chemistry.

Substance in chemistry

When we are talking about chemistry, we are actually talking about a study of different substances in the world. The basis of such substances are of course the elements on the periodic table, and for more advanced people they will learn about compounds, which are basically combination of the elements.

Structural Formula Wallpaper Adrenaline Chemistry
Structural Formula Wallpaper Adrenaline Chemistry

We will study carefully about the properties of the above substances, like at what temperature will the substance melt or condense, and what are the colors and appearance of the substance so that we can identify it. Of course we will also need to know whether or not the substance is toxic or in other way harmful to human beings.

However, this is only what we do when we are learning the basics of chemistry, and there is nothing to do with synthetic organic chemistry.  

 

Discovery of new substance is too slow

Stepping into the modern era, the demand for comfort and convenience in ur daily lives are sky high. However, let us look at how the substance or elements are discovered in normal chemistry study—they are discovered naturally. This is a random process of discovering elements and substance by observation and random experiments.

The problems of this is that it is too slow and not focused. People often have a demand for better lives and they will therefore need some substance having a particularly property—maybe a super glue or some substance that will not be attached to dust or something that is super easy to clean.

Another problem for this normal way of discovery is that we cannot guarantee that the next substance of materials being discovered are the one that we want. We may end up finding something toxic. Therefore, we will need something that is more focused in finding the substance that we want.

microscope
microscope

A focused study to create new materials

Under this background, we can explain why the technique of synthesis are so useful to us. Synthesis is a unique way of doing experiment, and the aim of that is to create or produce new substance or compound. So, the starting point of doing synthesis is to make new substance, and particularly, the substance that we want.

The process of doing a synthesis is quite difficult and it often involves quite a number of execution for chemical reactions. Besides, the success rate for such a synthesis is still low, although obviously it will be much higher than the aforementioned random way of finding the right materials. Therefore, it would be a long journey before any new substance are really being found.

scientist
Slow qualitative research

This is what synthetic organic chemistry is about—it is mainly a sub-field of synthetic chemistry in which scientists are dedicated to create and obtain new organic materials by the method of synthesis.

What are organic materials? It is just a group of chemical compounds or elements that contain at least one carbon atom. This is one way of classifying the materials and substances in the world but this is an important one. This is because usually organic materials are much more complicated than inorganic one and therefore we will usually pay more attention to study the organic materials. This is also what synthetic organic chemistry do, but they aim is not to study but to create.

Influence of PSD method development on Sedimentation Process

Industries always consider particle size distribution in the treatment of water.

It helps in the PSD method development on sedimentation process of storm water treatment. This is done by the removal of heavy metals or solids and pollutants. The velocity or speed of the sediments are determined by the shape, size, density and texture of the particles.

Notions Guiding PSD in the Removal of Sediments

The first is the belief that the size of particles influences the settling speed or velocity of the particles. That is, the weight of the particles, which is based majorly on how big or small they are, determines how they settle. Also, it is of the notion that the coming together or concentration of metals depend solely on their sizes.

bubble

Instruments of PSD Sedimentation Process

Detention ponds

These are the common PSD method development on sedimentation methods industries use in water treatment and pollutants removal. The operations of the detention ponds depend on the size of the ponds, detention time and the conditions of mixing.

Detention time = pond volume ÷ inflow. Inflow is the highest flow rate of rain that falls on impermeable surface. To model the removal performance,  fully mixed condition must represent the minimum percent while the quiescent condition is the maximum percent.

Hydrodynamic Seperators

They are one of the PSD method development on sedimentation process’ devices industries use to treat stormwater. They calculate the percent removal as a function of settling velocity and flow. In its calculation, it takes in the consideration of some  variables, such as the diameter of separator, the depth of water, removal efficiency, and pecelet number.

Heavy Metals

Metals absorb with sediments. Small sediments attract more metals while particles of large sediments attract lesser metals. Large particles have large surface area per mass and large settling velocities. Thus, large particles retain more in the sedimentation process.

Summary

The PSD method development is an important feature that helps in the water treatment by the use of sedimentation  practice.

 

Challenges facing active pharmaceutical ingredient production

Active pharmaceutical ingredient (APIs) production face also of problems especially china and India.

The following are challenges facing API companies.

Pharmacie, drugs, Generic drug

Regulatory Problems

In this is inspection. When API industries are not thoroughly inspected defective products will not be detected however, this may cause life- threatening products or even ineffective commodities in the hand of the public.

The regulatory system must ensure that API production companies operates under legality however, lack of inspection will lead to defective products distributed to the public.

API production companies have failed to follow the rules and regulation passed by the regulatory board. Many industries are ignoring the public health and are motivated by greed through practicing fraud or illegality intentionally.

API production companies have faced challenges of controlling repacking and relabeling of products by other people hence duplication of API products.

Limited Approval of New Chemical Entities

In the past few years the rate of new chemical entities has declined rapidly. This is according to the research done by IMS.

The reason behind this decline due to the increase of high safety standards and scrutiny by FDA (food and drug administration authority).

Products Delays and Non-Approvals

It takes 10-12 years for a new medicine to be approved from launch to distribution

Increased generic competition

In this case big API production companies spends millions of dollars from discovery to product launch. This process takes years hence bringing delay to approval.

Technology Transfer

Technology transfer is associated with risk that require management. Transfer of technology from one culture to another is complex and more complicated due to the cultural differences of the involved sites of the organization. In this aspect technical skills are also required for the facilitation of the operation. Training and development of employee’s skills must be established in order to catch up with the new technology discovered.

Regulatory Aspects

Due to the short timeline given by the regulatory, it’s difficult to cope with the challenges of the manufacturing sit directed by the regulatory system.

Active Pharmaceutical Ingredients and Grecian Era

Nowadays, essentially anybody recognizes  “active pharmaceutical ingredient “.

 

Regardless of the possibility that you some way or another is unaware of it. now, studying the word presumably think about what it implies. Active pharmaceutical ingredient alludes to the complex (or mixes) inside of something (generally a type of prescription) that really delivers the consequence of the medicine. Definitely many components must be devouring in ludicrously little amounts. Moreover creating drugs in that quantity is fiercely unfeasible. Therefore, they are blended with (sometimes a lot) Compound in an effort to create a achievable product. Mostly these are impetuses, without which the l lively pharmaceutical ingredient can not operate properly.

However, within the term pharmacy has exceptionally old roots.

 

The term Pharmacy originates from the Grecian text “Pharmacos”. It was initially utilized in portrayal of medicines or herbs That they believed hadhat they believed had remedy (or even enchanted properties). Yes, enchantment! While straightaway we might daydream of primitive Greece as rampart of insightful, advanced, clever and groundbreaking minds, this is essentially in light of the fact that the vast majority of our surviving writing and composing are from the masterminds of that era. They were the contingency, rather than the rule, and the mass uphold then as breath of life with enchanting qualities.

 

1: Active pharmaceutical ingredient contains active complex

2: Orginates from the Gracian term “Pharmacos”

3:In precedent days several thought recovering as a kind of Enchantment

 

For instance, in barbaricFor example, in antiquated Rome,  a herb that was such a powerful type of anti-conception medication, that they really ate it out of the earth!It is extint. Though, we grasp about its life at the hand of saved scripts and records.. Besides, they even delivered it on their coins! It is clear beyond a shadow of a doubt to see at which point such things are regared with an essence of magic within the primitive world.

 

Downstream processing: An Intro

Downstream processing is the process of making new medicines and biosynthetic products from natural resources. These natural resources can be anything from animals to plants and even the bio-waste. The process of downstream processing includes the proper management of other resources as well like water management.

Uses of downstream processing:

  •    To make antibiotics:

Downstream processing is very useful to make the antibiotics as they use biological and natural resources to make these medicines.

  •    To make hormones:

Once upon a time hormones were considered only to be produced by the human body naturally. By using downstream processing, it is now possible to make very useful hormones like insulin and human growth hormones.

  •    Vaccines:

Vaccines made by the natural resources are proved to be more effective and do not have side effects.

  •    Flavors:

This is a new concept in the biotechnology field. But it surely is a good way to make flavors. The artificial flavors were sometimes considered to be harmful but the flavors mad by downstream processing by using natural resources are safe.

The downstream processing comes under the specialization field of biotechnology and chemical engineering. This process has significantly changed the medical industry as they do not have to make new medicines from non-biological compounds. That process was lengthy and it further created by products like polluted water.

This process includes various processes in it. It takes four steps to get the final product through downstream processing.

  1.    Capture:

This includes the process of removing the colloidal material from the main solution.

  1.    Product isolation:

Product isolation is the removal of those materials whose properties differ from the main solution.

  1.    Intermediate purification:

This process includes the removal of bulk contaminants such as host cells and other types of viruses.

  1.    Product polishing:

Product polishing is the refinement of the final product until they become the desired product.

This was the introduction to the downstream processing. There will be a series of articles about the various processes include in the downstream processing.

Hope this articles helps you.

How Chromatography came into existence?

Chromatography is a versatile strategy for separating a wide range of chemical mixtures.

In the mid 1900s, Mikhail Tswett, a Russian botanist took keen interest in individual chemical

compounds found in plants. He noticed that removing ground-up plant material extracts with various

solvents delivered diverse shaded solutions. One of his trials included pouring a plant extricate through a

glass tube stuffed with powdered calcium carbonate. As the fluid went by the solid powder, different

bands of colors showed up; these were the different compounds, separated from each other by the mere

interaction of the solid and the fluid extract. By this, he had invented Chromatography, the word which

was drived from Graphe means writing and Chroma means color.

From that point forward, chromatography has turned into a foundation of separation science, that branch

of science dedicated to separate compounds from mixtures. There are two principle classes of

Chromatography: Analytical and preparative.

 Analytical work utilizes little specimen sizes; the goal is to separate mixes so as to distinguish

them.

 Preparative work utilizes huge amounts of tests and gathers the yield in mass; the purpose of the

Chromatography here is to expel polluting influences from a business item.

In any chromatographic strategy, a stationary stage more often than not a strong, thick fluid, or reinforced

covering that stays settled in one spot, and a versatile stage oreluent (normally a fluid or gas) travels

through it or crosswise over it.

An example to be isolated, when set on the stationary stage, will slowly move along in the same bearing

as the versatile stage. On the off chance that a specimen compound (or analyte) has no cooperation with

the stationary stage, it will run directly through and leave the framework (elute) at the same rate as the

versatile stage. Then again, if an analyte has no cooperation with the portable stage, it will stick

straightforwardly to the stationary stage and never elute. Neither of these are great results.