Overview of oral solid dose (OSD) dosage manufacturing, specifically film coated tablets, complex modified release tablets & controlled substances.
Q1. Tablets, what are they and what are the different types available in the pharmaceutical industry?
Pharmaceutical tablets are solid oral dosage forms prepared by compressing a drug (API) with or without diluents. Tablets function as unit doses that deliver the desired quantity of active pharmaceutical ingredients (API) to the end consumer with unparalleled accuracy.
There are various dosage forms including liquids, sprays, injectables, creams, suppositories, etc. However, the preferred dosage form by a large margin, remains to be oral solid dose (OSD) dosage forms. Commercial drug product manufacturing trends show that oral solid dose (OSD) dosage forms continue to play a major role in the pharmaceutical contract manufacturing and CDMO industry, representing about 70% of the market.
Oral solid dosage outsourcing trends further reveal that despite the increasing types of biologics, oral solid forms such as tablets & capsules remain dominant in the commercial market. The ease of administration, identification, and relatively better taste assert pharmaceutical oral solid dosage forms as one of the leading modes of drug administration.
Pharmaceutical solid oral dosage forms are preferred formulations for drug delivery. Tablets have the greatest dose precision, lowest content variability, lowest cost, and various other favorable qualities that make them a desired choice amongst pharma CMOs and CDMOs offering formulation development services (contract development services).
Furthermore, tablets offer flexibility as oral formulations and are available as the following types (amongst others):
- Film coated tablets
- Enteric coated tablets
- Buccal tablets
- Extended release tablets
- Complex modified release tablets
- Sustained release tablets
- Effervescent tablets
- Chewable tablets
- Compressed tablets
- Sugar-coated tablets
Q2. How are tablets formulated and what are the manufacturing aspects of film coated tablets?
Tablet formulation development and manufacturing is a stylized process. Each Pharma CMO and CDMO (contract development and manufacturing organization) uses their own pharmaceutical formulation development and manufacturing methodology. Some use the systematic design of experiments (DOE) approach, some test one variable at a time, and many use a combination of the two.
The pharmaceutical formulation development and manufacturing of tablets is completed in the following steps:
Step 1. Preformulation Studies: Preformulation is the stage of development in the pharmaceutical industry, during which physicochemical properties of drug substances are characterized and established.
This could provide important information for formulation design or anticipate the needs for molecular modifications. Every drug has intrinsic chemical and physical properties which need to be considered before the formulation development and manufacturing of pharmaceutical drug products such as film coated drug products.
Step 2. Dispensing: The first step in tablet development and formulation, after preformulation studies have been conducted and appropriate oral formulations have been chosen, is called dispensing. Dispensing involves weighing all the ingredients in tablets accurately to ensure desired API & excipient amounts in the tablet formulations.
Step 3. Sizing: The second step in tablet formulation development is known as sizing. During sizing the active ingredients and pharmaceutical excipients used in tablet formulations are broken down to a finely divided forms, to augment flow properties and enable easier mixing of ingredients.
Step 4. Powder Blending: Powder blending uses cutting edge technologies to mix powders and achieve homogeneous mixtures. This step of tablet development and formulation gives blend uniformity and distributes lubricants evenly in the resulting powdered mixture.
Step 5. Granulation: Most fine pharmaceutical compounds require the formulation development process known as granulation, offered by pharmaceutical CDMOs to improve flow properties and processing properties prior to tableting. Granulation can be divided into two types: dry granulation and wet granulation.
Step 6. Drying & Dry Screening: If the wet granulation route of tablet formulation development is used in the previous step, then it is followed by drying and dry screening. Dry screening in tablet development refers to passing the dried granules through a mesh screen to undergo compression.
Step 7. Tablet Compression: The process of tablet compression involves the rearrangement of particles to eliminate voids and create compact dosage forms. The term “direct compression” is defined as the drug product formulation development process in which powdered mixtures of APIs and suitable excipients are directly compressed to form a tablet.
Direct compression (DC) is by far the simplest means of tablet formulation development and commercial manufacturing, as it only requires the active pharmaceutical ingredient (API) to be properly blended with appropriate excipients before compression. Direct compression further reduces costs, reduces formulation steps, and accelerates time to progress to commercial marketing. Direct compression is thus one of the preferred methods for formulating tableted oral solid dosage forms.
Step 8. Coating: Tablets are coated to achieve taste masking of bitter drugs and unpleasant odors associated with the pharmaceutical oral formulations. During the pharmaceutical development of film coated drug products, controlled release formulations, modified release drug products (modified release tablets), etc. coatings can change release profiles of the oral solid dose (OSD) dosage forms.
Complex modified release tablets can be formulated using coatings. Coating is thus an imperative product design and development service required to go from drug product development to commercial manufacturing of modified release formulations e.g. sustained release tablets.
After direct compression, tablets can be coated in various ways to achieve different formulations. Film coating is a common step in modified release tablet manufacturing that can be used to improve product appearance, organoleptic properties, or to facilitate swallowing. Functional film coats can also be used as a part of the product’s stabilization strategy and to modify or delay drug release of film coated drug products and sustained release tablets.
Therefore, the drug product development & commercial manufacturing aspects kept in mind during the production of film coated drug products (film coated tablets) include the shape, size, stability, and color of the dosage form, as well as the desired release profile of the tablets.
Q3. What are complex modified release tablets? What advantages do they offer over other solid oral dosage forms?
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 controlled release formulations.
If we look at CDMOs (contract development and manufacturing organizations) and pharmaceutical contract manufacturing for oral formulations, focusing on classic and complex oral solid dosage forms (OSD), it encompasses powders, granules, tablets, including press coated tablets and multi-layer tablets, and capsules amongst a variety of other oral solid controlled release formulations.
Oral controlled release drug delivery products are further differentiated on the basis of their timed release profiles into the following types:
1. Immediate Release
An oral solid dosage form with an instant release profile expels the active ingredient immediately after the drug product is swallowed and reaches the stomach.
2. Sustained Release
In sustained release there is a sustained release drug delivery of the drug product at a predetermined rate by maintaining a constant drug level for specific periods of time e.g. extended release tablets.
3. Controlled Release
Controlled release formulations are released into the body in specified amounts over a specified period of time. The controlled-release drug delivery system is designed to release the active pharmaceutical ingredient gradually over the day. Modified release tablet manufacturing is achieved via controlled drug release methodologies.
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 dosage forms (extended release tablets), falling under modified release dosage forms , have a modification in their release mechanism, which is developed by altering drug absorption or the site of drug release in order to achieve predetermined clinical objectives. The modified release tablet manufacturing is achieved via controlled drug delivery methods, hence, complex modified release tablets have altered release profiles which can slow down or speed up the release of drugs as compared to conventional pharmaceutical solid oral dosage forms.
Modified release tablet manufacturing is achieved via controlled drug release methods, involving both delayed and sustained release mechanisms of action for oral administration. These delivery mechanisms alter the timing or rate of release of active pharmaceutical ingredients to successfully modify the expulsion of poorly water-soluble drugs in the body.
Complex modified release tablets offer numerous advantages over traditional oral formulations, including:
- Tailoring of drug release rates
- Protection of fragile drugs
- Reduction in blood level fluctuations
- Protection against dose dumping
- Increased patient comfort and compliance
- Bioavailability enhancement
- Improved solubility
- Attenuation of adverse effects
Q4. What are modified release technologies?
Oral controlled release technologies have been in existence since the early 60’s and have gone through a plethora of modifications and advances over the years. Controlled release technologies encompass modified release technologies and enable the production of modified release drug products e.g. modified release tablets. Some of these modified release technologies are listed below.
Film coating: Modified-release (or functional) film coatings are used when drug release characteristics need to be modified. Modified release tablet film coatings may be further categorized as either delayed-release (e.g. gastro-resistant/ enteric coating) or extended-release coatings.
Multiparticulate technology: The Multiple-Unit Pellet System (MUPS) is a multiparticulate formulation system that has become an important and successful dosage form for immediate or modified drug release. These multiple unit systems allow complex modified release of drugs. The MUPS manufacturing process consists of 2 steps: (1) Pellets manufacturing and (2) Tablet containing pellet formulation. This equips them with the advantages of both tablets and pellets in one dosage form
Bi-layer tablet: Bilayer tablet technology helps in separating the incompatible substances in which one layer is immediate release as loading dose and second layer is controlled/sustained release as maintenance dose. Two incompatible drugs can also be formulated into a bilayer tablet by adding an inert intermediate layer.
Matrix technology: Today, most time-release drugs are formulated so that the active ingredient is embedded in a matrix of insoluble substance(s) (e.g., modified ethyl cellulose or acrylic polymers) such that body fluids pass through the matrix dissolving the drug which then must find its way out through the holes in the matrix. In some modified release formulations, such as modified release tablets, the drug dissolves into the matrix, allowing the drug to exit through the outer surface.
Q5. How does scale-up (technology transfer) occur from development to commercial manufacturing of tablets containing controlled substance drug products?
A controlled substance/controlled drug is a chemical or drug whose development and distribution is tightly regulated by the government. Therefore, controlled substances can refer to illicit drugs like stimulants and opioids or to prescription medications like morphine, valium, and Ritalin. Manufacturing controlled drugs must be closely monitored, and the process must be implemented on a global scale.
The DEA controlled substance or DEA-controlled compound market is growing rapidly, driven by trends in oncology and increased access to treatment for neurological disorders. Contract drug manufacturing for DEA controlled substances offer solutions for the safe and secure development and manufacture of DEA controlled substances or DEA-controlled compounds.
Controlled substance manufacturing and use of controlled drugs is restricted to avoid drug abuse and addictions. Controlled substance manufacturing offered under contract drug manufacturing is similar to other dosage forms going from drug product development to commercialization with the help of scale up and technology transfer services.
- Scale up is generally defined as the process of increasing batch sizes. In process scale-up, a formula is transformed into a viable, robust product by the development of a reliable and practical method of manufacturing that affects the orderly transition from laboratory to routine processing in a full-scale pharmaceutical contract manufacturing facility. It must include a close examination of the formula to determine its ability to withstand an aggregation of batch-scale and process modification concerns.
QbD: In pharmaceutical product design, scale up may be accompanied by quality by design (QbD) studies. QbD approaches can be used to validate analytical methodology, assess variability, perform method optimization of sample collection time intervals, and provide other information in a small number of subjects before proceeding with a full-scale bioequivalence study prior to commercial drug product manufacturing.
- Technology transfer is a process to transfer information and technologies necessary for contract drug manufacturing of quality drug products consistently, or it’s the process of taking an invention from its inception in a laboratory to commercial drug product manufacturing. This stage of development has its share of complex transfer requirements and pharmaceutical product design complexities. CDMOs for formulation tech transfer are involved in creating standard operating procedures, for master batches that demonstrate perfect scale-up working conditions in kilo labs, which are then replicated at a large-scale after cGMP requirements compliance is achieved.
CDMOs (contract development and manufacturing organizations) offering controlled drug formulation, development, and delivery services, include scale-up and tech transfer within their expertise. As a result of these activities, a milligram preparative method becomes a multi kg process, without impacting the quality or the performance of the controlled substance drug products.
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Pharma Service : Drug Product Manufacturing
92
Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.
Pharma Service : Drug Product Manufacturing
93
Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.
Pharma Service : Drug Product Manufacturing
EFFERVESCENT TABLET CONTRACT MANUFACTURI...
Category : Tablet
Sub Category : Effervescent
Pharma Service : Drug Product Manufacturing
94
Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.
Pharma Service : Drug Product Manufacturing
95
Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.
Pharma Service : Drug Product Manufacturing
96
Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.
Pharma Service : Drug Product Manufacturing
97
Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.
Pharma Service : Drug Product Manufacturing
98
Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.
Pharma Service : Drug Product Manufacturing
99
Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.
Pharma Service : Drug Product Manufacturing
100
Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.
Pharma Service : Drug Product Manufacturing
HIGHLY POTENT TABLET MANUFACTURING
Category : Tablet
Sub Category : High Potency APIs (HPAPIs)
Pharma Service : Drug Product Manufacturing
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