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Overview of controlled release formulation development and manufacturing of complex modified dosage forms including modified release tablets

Q1. What is formulation development and why is it important?

Fully integrated CDMOs offer CDMO services including drug formulation, development, and delivery. Pharma CDMOs which work on formulation development studies determine the specialist dosage forms, composition, and development and manufacturing routes, fundamental to drug product formulation. Pharmaceutical formulation development and contract services at times pertain to capsules filled with tablets, powder, granules, pellets, etc. and cover several other drug formulations.

Essentially, formulation development and manufacturing are performed in order for drugs to be effectively delivered to patients. The importance of these specialized services is exemplified by industry analysts, who speak to the advancement of formulation development & manufacturing in drug delivery platforms and personalized medicines.

Q2. How are oral solid dosage forms such as capsules and tablets formulated?

Oral solid dosages such as tablets and capsules employ oral drug delivery mechanisms, while drugs that are not orally administered use parenteral drug delivery systems. Traditional development and manufacturing of solid oral dosage forms starts with preformulation studies testing the physiochemical characteristics of active pharmaceutical ingredients (API) and excipients in order to design the desired formulation with process optimization.

Following preformulation, drug-excipient compatibility tests and prototype stability studies are conducted. The oral solid dosage forms are then subjected to batch scale-up after which they are transferred to commercial manufacturing units. The end goal of the formulation development of oral solid dosage forms is to improve the bioavailability of drugs and to optimize drug delivery.

Q3. What are the different types of oral solid formulations on the basis of their timed release profiles (Instant Release/Sustained Release/Controlled or Modified Release)?

Drug products are often classified into typical or complex formulations, complex drugs include products with complex active ingredients, complex routes of drug delivery, or complex dosage forms such as CDMO controlled release formulations.

If we look at CDMO oral formulations and oral applications, focusing on classic and complex oral solid dosage forms (OSD), it encompasses suspensions, powders, granules, tablets, including press coated tablets and multi-layer tablets, and capsules amongst a variety of other controlled release formulations.

Oral controlled release drug delivery products are further differentiated on the basis of their timed release profiles into the following types:

Immediate Release

- An oral solid dosage with an instant release profile expels the active ingredient immediately after the drug product is swallowed and reaches the stomach.

Sustained Release

- In sustained release there is a controlled release drug delivery of the drug product at a predetermined rate by maintaining a constant drug level for specific periods of time.

Controlled Release

- Controlled release formulations are released into the body in specified amounts over a given period of time. The controlled-release drug delivery system is designed to release the active pharmaceutical ingredient gradually over the day.

Q4. What is the mechanism of action of controlled release drug delivery systems (DDS)?

Looking at CDMO controlled release formulations, we now assess the development of modified-release dosage forms with controlled release drug delivery systems; for example, CDMO modified release tablets. The development of modified-release formulations is achieved via controlled drug release methods, involving both delayed and extended release systems of oral administration. These delivery mechanisms alter the timing or rate of release of active ingredients to successfully modify the expulsion of poorly water-soluble drugs in the body.

CMO controlled release formulations employ controlled delivery expertise in drug product development and controlled-release drug-delivery technologies, in order to develop a controlled-release tablet which adjusts API intake by expelling the desired therapeutic agents to the right part of the gastrointestinal system at the right time, for long periods in the body.

Controlled release drug delivery systems offer numerous advantages over traditional methods, including tailoring of drug release rates, protection of fragile drugs, and increased patient comfort and compliance. Modified oral drug delivery technology further achieves bioavailability enhancement for oral solid dosage forms.

Q5. What are extended and delayed modified release oral dosage forms? What are their advantages and disadvantages?

A CDMO offering controlled release formulation development and manufacturing, often concentrates on customizable drug delivery platforms for controlled release profiles, which include controlled release or modified release formulations.

Companies can use their annex of technology transfer CDMO services to provide modified release formulations with timed-release profiles to solve technological challenges. CDMO modified release tablets and capsules improve the bioavailability of drugs by making them more soluble and hence easier to absorb in the body.

Controlled Release Formulations:

Extended: Extended complex modified-release of oral solid dosage forms allows a reduction in dosing frequency and are designed to release the medication in a controlled manner by using Controlled Release Technologies (CRT), at a predetermined rate, duration, and location in the body to achieve and maintain optimum therapeutic blood levels of the drug. This technology makes it possible to retain a drug in the stomach for an extended period of time.

Delayed: Whereas, development of modified-release dosage forms employing delayed release, expel the drug at a time other than promptly after administration and also creates a delayed release for specific site delivery. The delay may be time-based or based on the influence of environmental conditions such as GI, pH, enzyme, and pressure.

Advantages and disadvantages of modified, customizable oral drug release forms:

Advantages of modified, controlled release profiles include sustained blood levels, improved solubility, reduced dosing frequency, attenuation of adverse effects, and improved patient compliance. Disadvantages include increased costs, slower onset of action, and prolonged side effects.

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