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Overview of the pharmaceutical formulation development & manufacturing of oral solid dose (OSD) dosage forms, specifically tablets & mini tablets.

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Overview of the pharmaceutical formulation development & manufacturing of oral solid dose (OSD) dosage forms, specifically tablets & mini tablets.

Q1. Tablet, what is it and how is it used in pharmaceuticals?

Pharmaceutical tablets are solid, unit dosage forms prepared by compressing a drug (API) with or without diluents. Furthermore, tablets offer flexibility as oral formulations in their use and are available as film coated tablets, enteric coated tablets, buccal tablets, lozenges, extended release tablets, complex modified release tablets, etc. each having their own benefits. 

- Complex-modified release tablets: The development of complex modified-release tablets is achieved via controlled drug delivery, involving both delayed and extended release systems of oral administration. These delivery mechanisms, employed in oral formulations like complex modified release tablets, alter the timing or rate of release of active ingredients to successfully modify the expulsion of poorly water-soluble drugs in the body.

Typical drug delivery methods include liquids, creams, sprays, injectables, suppositories, etc. However, the preferred dosage form by a large margin, remains to be oral solid dose (OSD) dosage forms. Solid dosage manufacturing trends show that oral solid dose (OSD) dosage forms continue to play a major role in the 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 market. The ease of administration, identification, and relatively better taste assert oral solid forms as the leading mode of drug administration. Besides tablet formulations and capsules, there are other types of oral solid dose (OSD) dosage forms, namely:

- Powders 

- Granules

- Sachets

 

Amongst these pharmaceutical products, tableted oral solid forms are the 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).

Active pharmaceutical ingredients (API) and excipients such as binders, lubricants, and fillers are the diverse ingredients present in tablets. In order to create a homogenous mixture, the process of blending is employed during tablet manufacturing to mix the excipients and APIs together. Ultimately, tablets function as unit doses that deliver the desired quantity of active pharmaceutical ingredients (API) to the end consumer with unparalleled accuracy. 

Q2. What are the steps involved in the drug product (formulation) development of tablets?

Pharma CDMOs that offer tablet drug product development services with access to well-equipped development, pilot scale and commercial facilities can work with tablet batches from a few hundred grams to full commercial production scale.

Tablet formulation development is a stylized process. Each Pharma CMO and CDMO 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. However, all formulators need a methodology that gives them reliable and useful information to identify problems before the formulation development of tablets begin.

 

The pharmaceutical formulation development of tablets is completed in the following steps:

1. Preformulation Studies: Preformulation is the stage of development in the pharmaceutical industry, during which the physicochemical properties of drug substances are characterized and established. This could provide important information for formulation design or anticipate the needs for molecular modification. Every drug has intrinsic chemical and physical properties which need to be considered before the formulation development of pharmaceutical products. 

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. 

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 finely divided forms, in order to augment flow properties and enable easier mixing of the ingredients in oral formulations.

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. 

5. Granulation: Most fine pharmaceutical compounds require the formulation development process known as granulation, offered by pharmaceutical CDMOs, to improve their flow properties and processing properties prior to tableting. Granulation can be divided into two types: dry granulation and wet granulation. 

In the pharmaceutical development industry, granulation may be defined as a pharmaceutical development service wherein small particles of drugs and excipients adhere together by forming bonds which result in the formation of large aggregates called granules. Contract development & manufacturing organizations (CDMO) and pharma CMOs offer such pharmaceutical contract manufacturing services.

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. This step in tablet development and formulation refers to drying wet granules after they have been screened. Dry screening in tablet development refers to passing the dried granules through a mesh screen to achieve the oral formulation ready to undergo compression.

7. Tablet Compression: The term “direct compression” is defined as the drug product formulation development process by which tablets are compressed directly from powdered mixtures of API and suitable excipients. Direct compression (DC) is by far the simplest means of tablet formulation development and manufacturing, as it only requires the active pharmaceutical ingredient (API) to be properly blended with appropriate excipients before compression.

8. Coating: Tablets are coated to achieve taste masking of bitter tastes and unpleasant odors of the pharmaceutical oral formulations. During the formulation development of tablets, coatings can change the release profiles of the oral solid dose (OSD) dosage forms. Complex modified release tablets can be formulated using coatings. Therefore, coating is considered as a major tablet drug product development service to modify the release profile of drug products.

Q3. What are pharmaceutical mini tablets and what are the benefits they offer?

Mini-tablets represent a new trend in solid dosage formulation development and manufacturing, with the main goal of overcoming some therapeutic obstacles. Pharmaceutical mini tablets are solid oral dosage forms with a diameter less than or equal to 3 mm, separated into subunits of conventional tablets. Mini-tablet formulation development is similar to standard tablets, but the only difference is the use of multiple punches. Pharma CMOs and CDMOs offer mini tablets drug product development services. 

Numerous CDMOs offer mini tablets drug product development services for pediatric and geriatric dosage forms since they are easier to swallow than conventional tablets and capsules. In addition, they can be used to meet a full range of dissolution profiles, including delayed-release, controlled-release, and combination-release. 

Mini tablets are multiple unit dosage forms and are better than granules and pellets as mini tablet manufacturing is easy to undertake, and they are more stable. Mini-tablets offer finished dosage form flexibility in that they can be delivered as capsules, sachets or compressed into larger tablets. 

These mini tablet drug delivery systems are ideal for delivering fixed dose combination pharmaceutical oral solid forms. In mini tablets drug product development services, one type of pharmaceutical mini-tablet can be mixed with another or with pellets, granules or powders and then filled into finished dosage forms in order to avoid incompatibilities in combination products.

 

 Mini tablet drug product development services offer various benefits, including but not limited to:

- Increase in productivity

- Acceleration in time to market

- Less risk of dose dumping 

- Ease of minitablet manufacturing 

- Mini tablet drug delivery systems are ideal for coating

- Mini tablet formulation development can produce formulations with various release profiles

- High drug loading 

Q4. What are the technologies involved in the formulation development of mini tablets?

In principle, mini-tablets development and formulation is similar to the larger, conventional tablet development and formulation. However, successful development of mini tablet drug delivery systems require specialist expertise as many drug product development issues are enhanced due to their small size. Mini tablet drug product development services are enabled by several tablet technologies developed for mini tablet development and formulation. Mini tablet pharmaceutical development services and the mini tablet formulation technologies that enable them, are explored below:

1. Dispensing:

Dispensing is performed with the help of weighing and measuring apparatuses and aims to accurately weigh out API, excipients & other ingredients that make a tablet.

2. Sizing:

Sizing drug product development services are carried out to reduce and obtain the desired particle sizes before later stages of development of mini tablet formulations. Sizing is carried out with the help of fluid energy mills, colloidal mills, ball mills, etc.

3. Blending/Mixing:

Blending or mixing is very important for the drug product development of oral solid dosage forms. Blending mini tablet drug product development services create homogenized mixtures for granulation followed by compression. Blending is carried out by using tumbling blenders, oblicone blenders, agitated powder blender and other mini tablet formulation technologies.

4. Granulation:

Granulation creates aggregates of adhered pharmaceutical oral solid forms that are ready for compression. This mini tablet drug product development service is achieved with the help of fluidized bed granulators, roto granulators, high shear granulation mini tablet formulation technologies, etc.