- Introduction to drugs and pharmacy
- New drug development and approval process
- Current Good Manufacturing Practices and Current Good Compounding Practices
- Drug Delivery Systems
- New concepts in pharmacology that influence design of DDS
- Impact of current trends in pharmaceutical product development on design of DDS
- Aims of DDS development
- Characteristics of an Ideal DDS
Introduction to Dosage Forms and Drug Delivery Systems
New Drug Development and Approval Process
- Stage 1
- Stage 2
- Stage 3
- What is the last step?
- Early drug discovery
- Pre-clinical phase
- Clinical phase
- Regulatory approval
is a set of regulations that was initially put forth by the FDA to ensure that business organizations, manufacturers, and packagers of pharmaceutical products, medical devices, blood, and certain foods proactively guarantee that their products are effective, safe, and pure.
Current Good Manufacturing Practice (cGMP)
is a formulation or a device that enables the introduction of a therapeutic substance in the body and improves its efficacy and safety by controlling the rate, time and place of release of drugs in the body.
Drug Delivery System
Ideal Characteristics of Drug Delivery Systems
- It should increase the bioavailability of the drug.
- It should transport the drug intact to the site of action while avoiding the non-diseased host tissue.
- The product should be stable and delivery should be maintained under various physiological variables.
- A high degree of drug dispersion.
- The same method should be applicable to a wide range of drugs.
- It should be easy to administer to the patient.
- It should be safe and reliable.
- It should be cost-effective.
Classification of drug delivery system
- Conventional DDS
- Novel DDS
Conventional DDSs are classical methods for delivery of a drug into the body.
Generally, these systems are used more often when the goal is quickly absorption of a drug; therefore, a quick release of the drug is required. The conventional drug delivery forms include simple oral, topical, inhaled, or injection methods.
These methods cannot keep the drug concentration at a fixed and constant level for a given period of time (temporal delivery). One solution to overcome the problem of drug instability concentration is administration of multiple doses at regular intervals (repeated doses).
However, this method has its own limitations.
The concentration of the drug varies up and down irregularly in blood plasma and the patient typically forgets to take the specific dose at its exact time. Due to the problems mentioned for conventional DDSs, the necessity of providing novel DDSs becomes more apparent.
Conventional DDS
is a combination of advanced techniques and new dosage forms to introduce better drug potency, control drug release, provide greater safety, and target a drug specifically to a desired tissue. The term “controlled release” has a meaning that goes beyond the scope of only sustained release action. In other words, controlled release must have two properties such as predictability and reproducibility in the release kinetics.
NDDSs lead to efficient use of expensive drugs and excipients, and reduce in production cost. From the patient point of view, NDDS brings better therapy by improved comfort drug delivery devices which increase the standard of living.
Novel drug delivery systems
Must have two properties such as predicability and reproducibility in the release kinetics
Controlled release
Novel drug delivery systems are divided into four categories including
- Rate-reprogrammed
- Activation-modulated
- Feedback-regulated
- Site-targeting DDSs
Drug Delivery Routes
- Gastrointestinal system
- Parenteral
- Transmucosal
- Transnasal
- Pulmonary
- Transdermal
- Intraosseous infusion
Examples of Gastrointestinal system delivery routes
- Oral
- Rectal
Parenteral routes examples
- Subcutaneous injection
- Intramuscular injection
- Intravenous injection
- Intra-arterial injection
Transmucosal route examples
- Buccal
- Through mucosal lining
- The rest of gastrointestinal tract
