CPI PHARMA

What are pharmaceuticals?

Medicines and drugs used for treating medical conditions.

What is the role of the pharmaceutical industry?

Responsible for the discovery, development, and manufacture of drugs and medicines.

What organization approves pharmaceuticals for market distribution?

The Food and Drug Administration (FDA).

What is the focus of pharmaceutical engineers?

Conception, design, construction, and operation of research facilities and manufacturing plants.

What is the role of pharmaceutical research and development?

Develop formulations and drug delivery systems for new products.

What do pharmaceutical technology and engineering support?

Pharmaceutical manufacturing and technology transfer.

What is the focus of chemical engineering research and development in pharmaceuticals?

Producing bulk pharmaceutical compounds for safety assessment and clinical trials.

What do bioprocess engineers do?

Link basic research with the commercial production of biologically derived products.

What is a drug?

Any substance used for diagnosis, cure, treatment, or prevention of a disease.

What are the sources from which drugs can be derived?

Plants, animals, minerals, chemicals, and recombinant DNA technology.

What is a synthetic drug?

A drug created artificially with a specific mechanism of action.

What is a semi-synthetic drug?

A drug that contains combinations of artificially created molecules and natural molecules.

List some reasons drugs may be prescribed.

Promote healing, cure disease, control disease progression, prevent disease, decrease risk of complications, increase comfort, reduce excessive activity.

What are the physical states drugs can exist in at room temperature?

Solid, liquid, or gaseous.

What is the typical molecular weight range for most drugs?

100 to 1,000.

How do drugs interact with receptors?

Through chemical forces or bonds, primarily noncovalent bonds.

What is the significance of drug shape?

It is important for the fit of the drug to its receptor, affecting binding and function.

What are chiral enantiomers?

Mirrored image twin molecules that can differ in their ability to bind to receptors.

What are drug-drug interactions?

When one drug affects the absorption, distribution, metabolism, or excretion of another.

What is a cumulative drug interaction?

Repeated administration of a drug produces effects more pronounced than the first dose.

What is an additive drug interaction?

The effect of two chemicals equals the sum of their individual effects.

What is the synergistic effect in pharmacology?

The effect of two chemicals taken together is greater than the sum of their separate effects at the same doses.

What is the antagonistic effect in pharmacology?

The effect of two chemicals taken together is less than the sum of their separate effects at the same doses.

What are therapeutic drug effects?

The desired action of a drug, which may include stimulating or inhibiting cell function.

What are mild side effects of drugs?

Unwanted effects that are generally not severe, such as dry mouth from antihistamines.

What are dangerous drug effects?

Effects that can cause tissue damage or are life-threatening, such as excessive bleeding.

What is RA 6675 in the Philippines?

The Generics Act of 1988, promoting the production and acceptance of drugs identified by their generic names.

What does RA 9502 address?

The Universally Accessible Cheaper and Quality Medicines Act of 2008, providing for cheaper and quality medicines.

What is the purpose of RA 9165?

The Comprehensive Dangerous Drugs Act of 2002, aimed at regulating dangerous drugs and repealing previous laws.

What does RA 8203 prohibit?

Counterfeit drugs, providing penalties for violations.

What is the focus of RA 10747?

The Rare Disease Act of the Philippines, addressing the needs of persons with rare diseases.

What are pharmaceutical raw materials?

Elements required to manufacture various drugs, derived from natural or synthetic sources.

What are Active Pharmaceutical Ingredients (APIs)?

Substances in pharmaceuticals responsible for the intended therapeutic effect.

What processes can be used to manufacture APIs?

Chemical synthesis, fermentation, recombinant DNA methods, and isolation from natural sources.

What is the purpose of APIs?

To induce pharmacological activity or other direct effects in the diagnosis, treatment, or prevention of disease.

Name a common API used for pain relief.

Paracetamol (Acetaminophen).

What is the role of excipients in pharmaceuticals?

Pharmaceutically inert substances that help deliver the active ingredient.

What are animal extracts in pharmaceuticals?

Compositions extracted from animals, including their cells, tissues, and organs.

What is the estimated size of the animal extract industry?

Approximately US $19.6 billion, growing at a rate of 4.7% annually.

What is the significance of the Medical Act of 1959?

It regulates medical practice in the Philippines.

What does Executive Order No. 218 strengthen?

The support mechanism for the Philippine Drug Enforcement Agency.

What are the potential sources of APIs?

Animal sources, plant sources, and herbal extracts.

What is the definition of an active ingredient?

The product responsible for the effect a medication is designed to have.

What is the role of biotechnology in API manufacturing?

Methods like fermentation and cell culture used to produce APIs.

What are some examples of common APIs?

Ibuprofen, Norfloxacin, Simvastatin, and Warfarin.

What is the function of fillers in pharmaceuticals?

To provide bulk and facilitate the delivery of the active ingredient.

What are drug intermediates?

Derivatives or chemical compounds synthesized from simpler compounds for later synthesis stages in drug production.

What types of drugs can be made from pharmaceutical intermediates?

Anti-allergic drugs, antineoplastic agents, anti-diabetic drugs, antibiotics, etc.

What is the current market value of the pharmaceutical intermediate industry?

Approximately US $8.4 billion.

What are herbal raw materials?

Extracts derived from natural sources like flowers, fruits, herbs, and roots used for manufacturing various products.

What is the estimated global market value for herbal raw materials?

US $584.3 billion, projected to reach US $225 trillion in the coming years.

What are excipients in pharmaceuticals?

Inactive substances used in drug formulations to aid in the manufacturing process and enhance the drug's effectiveness.

Name three types of excipients used in pharmaceuticals.

Binder excipients, disintegrant excipients, and preservative excipients.

What is the role of the FDA in pharmaceutical manufacturing?

To govern research, development, and manufacturing practices to ensure safety and compliance.

What do Compliance Policy Guides (CPGs) provide?

Guidance on regulatory issues related to FDA laws and policies for industry compliance.

What is outlined in the Code of Federal Regulations (CFR) regarding pharmaceuticals?

Minimum current good manufacturing practices for drug product preparation.

What is the significance of active pharmaceutical ingredients (APIs)?

They are the active components in medications that provide therapeutic effects.

What is the purpose of sterilization and aseptic processing in API manufacturing?

To ensure the production of sterile APIs in compliance with CGMP regulations.

What are the key responsibilities of personnel in pharmaceutical manufacturing?

To approve and reject raw materials, labels, and APIs, ensuring quality control.

What factors are critical in the design of pharmaceutical manufacturing facilities?

Lighting, ventilation, air filtration, plumbing, and sanitation.

What is the first step in the pharmaceutical manufacturing process?

Dispensing, where the weight of each ingredient is determined.

What is the importance of sifting and sizing in tablet manufacturing?

It ensures proper size reduction and uniformity of the ingredients before tablet formation.

What are the two primary requisites imparted by granulation in tablet manufacturing?

Compactibility and fluidity.

What is the role of coating in drug formulation?

To facilitate easier ingestion, provide timed or targeted release, and enhance flavor and appearance.

What are some methods of tablet manufacturing?

Granulation (wet and dry), direct compression, and various unit processes like blending and drying.

What is the significance of using nanoparticles in drug formulation?

To encapsulate active ingredients, reducing required doses and improving specificity.

What is the consequence of manufacturing APIs not in accordance with CGMPs?

The APIs are considered adulterated under FDA regulations.

What is the purpose of validation in pharmaceutical manufacturing?

To ensure that processes and equipment consistently produce quality products.

What are microbiological tests used for in pharmaceutical laboratories?

To identify impurities and ensure the sterility of products.

What is the role of packaging and labeling in pharmaceutical manufacturing?

To ensure proper identification, dosage, and safety information for the end user.

What is the importance of control of raw materials in pharmaceutical manufacturing?

To ensure quality and safety of the ingredients used in drug production.

What is the significance of in-process controls during manufacturing?

To monitor and ensure the quality and consistency of the product throughout the manufacturing process.

Why is uniform particle size important in tablet manufacturing?

Uniform particle size provides greater uniformity of dose and enhances the mixing or blending of solid pharmaceutical ingredients.

What are the advantages of smaller tablets?

Smaller tablets have increased surface area for better dissolution rates, improved tablet-to-tablet content uniformity, controlled particle size distribution, enhanced flow properties, and uniform drying.

What is granulation in the context of tablet manufacturing?

Granulation is the process that provides homogeneity of drug distribution in the blend and is critical for achieving proper granule quality before tableting.

What are the critical parameters during the granulation process?

Critical parameters include dry mixing, impeller speed, chopper speed, mixing time, kneading during binder addition, and kneading at slow speed.

Why is drying a crucial step in pharmaceutical product development?

Drying is essential to keep residual moisture low, preventing product deterioration and ensuring free-flowing properties.

What types of dryers are commonly used in the drying process?

Commonly used dryers include fluidized-bed dryers, vacuum tray dryers, microwave dryers, spray dryers, freeze dryers, turbo-tray dryers, and pan dryers.

What are the critical parameters during the drying process?

Critical parameters include drying inlet temperature, outlet temperature, product bed temperature, and Dutch sieve integrity.

What challenges are associated with blending powders in tablet manufacturing?

Challenges include achieving perfect homogeneity, inherent cohesiveness of particles, and segregation due to differences in size, shape, and density.

What is the role of lubrication in tablet manufacturing?

Lubrication is necessary to prevent sticking during compression and must be carefully monitored to avoid over-mixing.

What types of blenders are used in the lubrication process?

Types of blenders include 'V' blenders, octagonal blenders, oblicone blenders, container blenders, tumbling blenders, and agitated powder blenders.

What is the purpose of compression in tablet manufacturing?

Compression is the process of forming tablets from granules or powders by applying pressure to achieve the final product shape.

What are the common stages occurring during the compression process?

Stages include the withdrawal of the top punch, filling the die with powder, adjusting powder weight with the bottom punch, and producing tablets with raised impressions.

What is the significance of packaging in tablet manufacturing?

Packaging is essential for protecting tablets during distribution and ensuring user safety and convenience.

What is a common form of packaging for tablets?

Blister packs are commonly used for packaging tablets, allowing users to see contents without opening the pack.

What critical parameters are involved in the packaging process?

Critical parameters include packing sealing roller and temperature.

What are liquid orals?

Liquid orals are liquid dosage formulations containing one or more active ingredients, with or without additives, dissolved in a suitable vehicle for oral administration.

Why are liquid pharmaceuticals preferred for some patients?

They are easier to administer to individuals who have difficulty swallowing solid dosage forms and are more rapidly absorbed than tablets or capsules.

What are the two main types of oral liquid dosage forms?

Solutions and dispersed systems.

What is a syrup in the context of oral liquids?

A syrup is an oral preparation in which drugs are homogeneously distributed in a solution.

What characterizes a suspension?

A suspension is a two-phase heterogeneous system where solid particles are dispersed in a liquid with the help of suspending agents.

Define an emulsion.

An emulsion is a two-phase system in which two immiscible liquids are homogeneously distributed in a liquid with the help of an emulsifying agent.

What are solvents in pharmaceutical formulations?

Solvents are chemical substances that can dissolve, suspend, or extract other materials without chemically changing either the solvents or the other materials.

What is purified water USP?

Purified water USP is water that is more free of solid impurities than ordinary drinking water and must not yield more than 0.001% residue when evaporated.

What are examples of preservatives used in liquid formulations?

Examples include phenol, chlorocresol, and benzoic acid.

What is the role of antioxidants in liquid formulations?

Antioxidants, such as ascorbic acid and sodium metabisulphate, are used to prevent oxidation and maintain product stability.

What is the significance of mixing in liquid formulation?

Mixing is essential to increase the flow of liquids and ensure uniform distribution of ingredients.

How can air entrapment be minimized during mixing?

By reducing agitator speed, conducting mixing under vacuum, or using a versator to draw off entrapped air.

What is the purpose of filtration in liquid formulation?

Filtration ensures that the final product exhibits the same degree of clarity as laboratory formulations and removes impurities.