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Overview of drug delivery technology for drug product manufacturing & more on CDMOs offering drug development solutions & manufacturing technologies.
Drug delivery is a process or method to deliver a drug to humans or animals in order to achieve a desired therapeutic effect. Pharmaceutical drug delivery technologies enhance drug absorption, efficacy, and patient experience.
Innovative drug delivery refers to approaches, complex formulations, oral manufacturing techniques, storage systems, and specialty formulation technologies involved in transporting a pharmaceutical compound to its target site to achieve a desired therapeutic effect.
Various types of dosage forms can be used to alter and enhance drug delivery. Common drug delivery dosage forms include solid dosage forms, such as capsules and pressed tablets, liquid dosage forms and parenteral dosage forms.
Drug delivery technologies have enabled drug development solutions for many pharmaceuticals that improve patient health by enhancing the delivery of a therapeutic or API (Active Pharmaceutical Ingredient) to its target site, minimizing off-target accumulation and facilitating patient compliance.
Advanced drug delivery technologies, in general, enable drug reformulation and administration routes, together contributing to life-cycle management and allowing an innovator to maintain product monopoly.
Some Types of Drug Delivery Technologies:
Oral Dose Technologies
Oral dosage forms such as oral solids continue to be the most commonly used delivery vehicles to get drugs to patients for three main reasons: they are cost-effective, relatively easy to manufacture, and most importantly, are patient-friendly.
As such, oral dose technologies have gained widespread importance in the pharmaceutical industry, for example, in complex formulations containing complex compounds or APIs. Various oral dose technologies are explored in detail in the following answer.
Controlled and Modified Release Technologies
Controlled and modified release technologies create pharmaceuticals that are designed to release drugs in vivo according to a predictable, therapeutically rational programmed rate to achieve optimal serum-drug concentration in minimal time.
Bioavailability Enhancing Technologies
Bioavailability enhancing technologies are being utilized to address complex bioavailability challenges and bring new compounds to market as well as repositioning existing compounds in life cycle management strategies which have poor solubility. Bioavailability enhancing technologies or bioavailability enhancement solutions may include micronization, nanosizing, crystal engineering, solid dispersions, etc.
Modified and Targeted Drug Delivery Technologies
Modified and targeted drug delivery technologies are advanced drug delivery technologies. Modified and targeted drug delivery are types of innovative drug delivery systems in which a medication is transported or concentrated selectively at the site of action to localize the interaction of a drug with the diseased site and to avoid the harmful effects to healthy tissue due to drug interactions.
Freeze Drying Technology
Freeze drying technology removes water from sensitive products without damaging them. Freeze drying technology has important applications in the pharmaceutical and biotechnology industries, and pharmaceutical freeze drying is now a standard process used to stabilise, store or increase the shelf life of drug products and other biologicals.
Oral dosage forms have always been considered the preferred dosage form for drug delivery due to lower unit dose cost and improved patient compliance. By the numbers, oral solid dosage or OSD drug products remain the largest segment of the pharmaceutical market.
Oral solids or OSD formulations can take several different shapes, and with those different oral dose forms comes different production technologies and facility designs. Therefore, having the ability to match each customer's molecule with the right enabling oral solid dose manufacturing technology is important.
Some Oral Technologies Used in Oral Solid Dose Manufacturing:
Granulation Technologies
Granulation is the process of particle enlargement by the agglomeration technique. Granulation is broadly classified into two types, dry granulation and wet granulation, with wet granulation being the most widely used granulation technique. Some common granulation technologies include spray drying, roller compaction, high shear mixing, and fluid bed granulation.
Direct Compression Technology
Direct compression technology enables the mixing and processing of OSD drug product ingredients followed by compressing the mixture into tablets. Direct compression (DC) is the most straightforward oral dosage manufacturing option for formulating oral solid dosage products such as tablets, with the fewest manufacturing steps, making it the easiest to control and the least expensive.
Coating Technology
Coating is a process by which an essentially dry, outer layer of coating material is applied to the surface of oral solid dosage products in order to confer specific benefits that broadly ranges from facilitating product identification to modifying drug release from the dosage form. Coating technologies include direct coating, the air doctor system, the table or rubber-blanket doctor system, lick-roller systems, reverse-roll coater, etc.
Taste Masking Oral Technologies
Taste masking is essential for various medications including geriatric and pediatric dosage forms. Taste masking oral technologies are applied to mask or overcome the bitter or unpleasant taste of active pharmaceutical ingredients or drugs to achieve patient acceptability and compliance for oral solid dosage products such as pediatric dosage forms. Taste masking technologies include fluid bed coaters, microencapsulation, spray drying, hot-melt extrusion, etc.
Specialized Oral Dose Delivery Technologies
Besides conventional oral technologies which are used for oral solid dose manufacturing, there are several specialized oral dose delivery technologies which are being explored for oral manufacturing of solid oral dosage forms.
Oral fast-dispersing dosage forms such as orally disintegrating tablets (ODTs), three-dimensional printing (3DP) and electrostatic coating are a few examples of existing specialty formulation technologies with the potential to accommodate various physicochemical, pharmacokinetic and pharmacodynamic characteristics of oral solid-dosage forms.
Advanced drug delivery technologies and drug delivery systems including nanocarriers, micelles, cyclodextrins and lipid-based carriers have also been explored to enhance the drug absorption of oral dose forms such as oral solid-dosage forms. Various other specialized oral dose delivery technologies, and oral dose design and development services which are not covered here, are also currently being explored.
Pharmaceutical organizations including contract development and manufacturing organizations (CDMOs) equipped with oral manufacturing technologies offer the outsourcing of oral dose design and development services, oral dosage manufacturing services and OSD formulations including modified release capsules, tablets and other personalized dosage forms.
Innovative drug delivery systems have the potential to make treatments safer and more effective, or more acceptable to patients. Controlled release oral delivery systems include any drug delivery system taken orally that achieves slow release of the drug over an extended period of time.
New formulation capabilities need to be developed and improved for more complex problems like bioavailability enhancing technologies, oral dose technologies for patient centric dosage forms like pediatric dosage forms, etc. Smart and controlled oral drug delivery can bypass physiological barriers that limit the oral delivery of therapeutics.
Recent developments in the area of controlled release oral delivery systems such as dome tablets, dual drug tablets, modified release capsules, intestinal patches, polymer nanosystems, or bioinspired drug delivery systems such as exosomes, have revolutionized the field of oral drug delivery. Significant advances have been made using micro and nanoscale technologies for innovative oral drug delivery as well.
Some Novel Technologies for Controlled Release Oral Delivery Systems:
Multiparticulate Systems
Recent trends indicate that multiparticulate drug delivery systems are especially suitable for achieving delayed or controlled release profiles of OSD formulations with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time. These dosage forms can be prepared by a number of techniques such as drug layering, spray-drying, spray congealing, rotogranulation, hot-melt extrusion and spheronization, etc.
Polymer Nanosystems
Polymeric nanoparticles (NPs) are particles between 1 to 1000 nanometers which can be loaded with active pharmaceutical ingredients (APIs) entrapped within or surface-adsorbed onto a polymeric core. Polymer nanoparticles (NPs) represent one of the most innovative non-invasive approaches for drug delivery applications. Polymeric NPs have shown great potential for modified and targeted drug delivery for the treatment of several diseases.
Exosomes
Exosomes are cell-derived nanovesicles that are involved in the intercellular transportation of materials. Many studies show that exosomes can efficiently deliver many different kinds of cargo to the target cell. Therapeutics, such as small molecules or nucleic acid drugs, can be incorporated into exosomes and then delivered to specific types of cells or tissues for targeted drug delivery including controlled release drug delivery.
There are many companies including CMOs, contract development and manufacturing organizations (CDMOs), etc which have formulation development capabilities and the latest specialty formulation technologies for outsourcing oral dose design and development and oral dosage manufacturing services for various dosage forms including controlled release drug delivery systems, formulations with complex compounds or APIs, and personalized dosage forms.
Drug delivery specialists, such as contract development and manufacturing organizations (CDMOs), equipped with advanced technologies and formulation development capabilities offer outsourcing drug development and manufacturing services, from early drug development solutions (early-phase development) to commercial manufacturing (commercialization).
Some organizations specialized in oral solids which offer OSD drug products such as controlled release tablets, modified release capsules, ODTs, solid formulations containing complex compounds and personalized dosage forms are noted below.
Adare Pharma Solutions - Bioavailability Enhancement Solutions
Adare provides technologies including controlled release and bioavailability enhancement for drugs with poor solubility together with its Optimum® technology, which are microspheres with high drug loading suitable for enteric coatings, taste masking and extended release oral applications.
Adare also offers commercial manufacturing or commercialization trains optimized for the global production and fulfillment of highly specialized oral dose technologies including bioavailability enhancement to address complex bioavailability challenges, controlled release, taste masking and orally disintegrating tablet (ODT) technologies.
Catalent Pharma Solutions - Early-phase Development and Manufacturing Drug Delivery Specialists
By utilizing its robust network of expertise and innovative technologies, Catalent offers the most comprehensive solutions from early drug development or early-phase development to commercial manufacturing or commercialization.
As the innovator of softgel technologies, Catalent RP Scherer softgel brings more than 80 years of drug development solutions expertise and offers early drug development and manufacturing services for the full spectrum of lipid-based drug delivery.
Catalent's Zydis® ODT fast-dissolve formulations are unique, freeze-dried oral solids that disperse instantly in the mouth. With more than 20 products launched in 60 countries, it continues to be the world’s best-in-class orally disintegrating tablets (ODTs) technology.
Skyepharma - GEOMATRIX and GEOCLOCK Tablet Technology
Geomatrix® (multi-layer tablet technology) is a patented innovative oral drug delivery technology of Skyepharma, which functions as both controlled and modified release technologies and provides a customisable drug delivery platform for controlled and modified release complex formulations of orally available molecules.
Skyepharma's Geoclock® (press coated tablet and tab-in-tab technology) allows controlled release drug delivery that is independent of food or pH. It can also be used for multiple pulse delivery of one or more drugs, or to target the colonic release of drugs. Skyepharma also has formulation development capabilities for producing modified release formulations.
PMC Isochem - Polymer Based Drug Delivery Specialists
PMC Isochem offers custom development and manufacturing services for Vitamin E TPGS (Tocophersolan) and amino acid based polymer drug delivery solutions. PMC Isochem has expertise in polyamino acid based drug delivery technologies.
Athena Pharmaceutiques - Bioavailability Enhancement Solutions
Athena offers a broad range of drug delivery platforms for innovative oral drug delivery such as bioavailability enhancement technologies for dealing with complex bioavailability challenges such as poor solubility, multiparticulate technology for controlled release drugs, extended release technology, etc. Moreover, Athena has developed a broad range of technology platforms for oral dose forms or OSD formulations with a special focus on modified release formulations.
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