Suckable & Chewable Tablet | Formulation Development

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Q1. What are chewable and suckable dosage forms?

Chewable Dosage Forms

A chewable dosage form is defined as a solid dosage form containing medicinal substances (active pharmaceutical ingredients) with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Chewable dosage forms are oral formulations which offer several benefits such as drug delivery without the need for water, ease of swallowing, stability, and patient-centric drug delivery, for example as pediatric drug formulations or pediatric dosage forms.

They are convenient pediatric products and are also suitable for the delivery of nutraceutical commercial products such as multivitamins. They act as good geriatric and pediatric drug formulations due to their desirable organoleptic properties and ease of administration. Chewable dosage forms have also found application in veterinary medicines. Chewable products largely include small chewable tablets and chewable soft capsules.

- Chewable Tablets

As per the USFDA, chewable tablets are oral formulations intended to be chewed and then swallowed by the patient rather than swallowed whole. They are designed to be palatable formulations of chewable tablets that can be easily chewed and swallowed. The active ingredients in chewable tablets may include antacids, antibiotics, anticonvulsants, analgesics, ant-asthmatics, vitamins, and cold preparations.

Chewable tablets must be prepared in such a way that they are user-friendly dosage forms which can easily be crushed by chewing as they are usually formulated for patients who have difficulty in swallowing conventional tablets. If chewable tablets are not prepared in such a way it can lead to gastrointestinal obstruction, tooth damage and esophageal irritation.

It is important to note that chewable tablets are not the same as effervescent tablets. Effervescent tablets are designed to release carbon dioxide upon contact with water, promoting their disintegration. Within a couple of minutes effervescent tablets completely dissolve into solutions. On the other hand, chewable tablets do not require water for administration.

- Chewable Soft Capsules

A softgel chewable capsule is another easy-to-swallow chewable dosage form for the convenient administration of medicines without water. They offer the advantages of portability, the elimination of messy liquids, taste-masking for unpleasant tastes and odors, etc. Chewable soft capsules are similar to normal softgels, except the gelatin is thinner and chewable.

Suckable Dosage Forms

A suckable dosage form is also a solid dosage form containing medicinal substances, but it is intended to be sucked rather than chewed. As suckable dosage forms are meant to be retained in the oral cavity they usually undergo taste masking which results in acceptable taste and pleasant mouthfeel, thereby increasing patient compliance.

The most common and widely known suckable formulations are suckable tablets or lozenges, other suckable formulations include medicated lollipops. Suckable dosage forms also make for good pediatric products or pediatric drug formulations.

- Suckable Lozenges

Lozenges are small medicated solid dosage forms that are designed to be held in the mouth for slow dissolution and disintegration. They usually contain one or more active ingredients and are flavored and sweetened so as to be pleasant tasting. Furthermore, lozenges often contain a demulcent to relieve inflammation or irritation of the throat.

- Medicated Lollipops

Lollipops are flavored medicated dosage forms intended to be sucked and held in the mouth or pharynx containing one or more medications usually in a sweetened base. Medicated lollipops are designed to improve patient compliance and acceptability.

Q2. What is the need for the development of chewable tablets?

Chewable tablets are user-friendly dosage forms that offer a convenient alternative to conventional tablets. The need for non-invasive delivery systems such as chewable tablets persists due to patients’ poor acceptance of, and compliance with, existing delivery regimes, limited market size for drug companies and drug uses, coupled with high cost of disease management.

Patient Related Factors

Chewable dosage forms such as chewable tablets are needed as they are more convenient for patients who have special requirements. Instead of swallowing intact, these dosage forms need to be chewed and then swallowed. Furthermore, they do not require water to swallow and can be taken at any time and place.

Humans learn to chew from an early age, making it a very natural process. Hence, most people find small chewable tablets very easy to take. Children and older adults differ in many aspects from the other subsets of the population and require particular considerations in medication acceptability.

Patient-centered pharmaceutical dosage forms like chewable tablets are thus required to improve patient compliance and enable the administration of medicines to geriatric and pediatric patients, people on the go, those who may not have ready access to water, etc.

Effectiveness Factors

Chewable dosage forms such as chewable tablets and capsules may have increased bioavailability and can provide faster onset of action. This is because they are subject to pre-gastric (oral, pharyngeal, esophageal) absorption being dispersed in saliva in the oral cavity. Pre-gastric absorption also prevents the first-pass effect and provides a significant advantage for drugs subject to hepatic metabolism.

Furthermore, safety profiles may be improved for drugs that produce significant amounts of toxic metabolites mediated by first-pass liver metabolism and gastric metabolism. Alternatives dosage forms such as chewable tablets are thus needed when faster onset of action is required as compared to liquid dosage forms, for drugs that are subject to hepatic metabolism, and those that produce toxic metabolites.

Manufacturing and Marketing Related Factors

A new dosage form allows a manufacturer to extend market exclusivity, unique product differentiation, value added product line extension and extend patent protection, while offering its patient population a more convenient dosage form. This leads to increased revenue, while also targeting underserved and under-treated patient populations.

Q3. What are the different factors considered for the formulation development of chewable tablets?

Various factors are involved in the formulation development of chewable tablets. The major formulation factors are disintegration, organoleptic properties, compressibility, stability, flow, lubrication, etc. which are common to regular and chewable tablets.

Critical quality attributes for the development of chewable tablets should also include hardness as well as factors that influence bioavailability and bioequivalence. In addition, careful attention should be given to tablet size, thickness, friability, and to the taste of the chewable tablet.

Some Factors Considered for the Formulation Development of Chewable Tablets:

Organoleptic Properties

In pharmaceuticals, organoleptic properties include drug substance appearance, color, taste, smell, etc. The organoleptic characteristics of chewable tablets that are important to consider for preparing user-friendly dosage forms include taste, after-taste, odor, flavor, texture, mouthfeel, and the visual aesthetics of the pharmaceutical products.

Hardness

Hardness is a force required to break a tablet across its diameter. The hardness of chewable products should be such that they withstand the rigors of full-scale commercial production or commercial manufacturing, packaging, shipping, and distribution, while being easy to chew by the intended patient population.

Disintegration

Ideal characteristics for chewable tablets include prompt disintegration to encourage dissolution. As soon as chewing starts in the mouth, the small chewable tablet is broken down into smaller particles from where dissolution and subsequent absorption occurs to affect the desired pharmacological action. This usually results in the enhanced bioavailability of medications.

Compressibility & Stability

Chewable tablets must have acceptable flow, compressibility and stability characteristics. Commercial manufacturing or the full-scale commercial production of chewable tablets is generally done using either wet granulation or direct compression.

The stability of a chewable tablet formulation is important mainly for the safety of the consumer and maintenance of quality over its shelf-life. The results of stability testing guide the establishment of storage conditions and the shelf-life of chewable products.

Lubrication

Lubricants are added to powder mixtures prior to tabletting to ensure that the tablet is ejected properly from the press. The addition of lubricants also affects tablet properties and can affect the behavior of the powder mixture. Lubricants and wetting agents are added to powder mixtures prior to tabletting in chewable tablets, fast-dissolving tablets, effervescent tablets, etc.

Taste Masking

The oral processing of chewable tablets makes taste masking a necessity for most formulations. Taste masking is defined as a reduction of undesirable taste that would otherwise exist. Taste masking can be achieved by using taste masking agents, specific flavours and sweeteners. Taste masking makes chewable tablets more appealing to consumers. Therefore palatable formulations of chewable tablets increase patient compliance.

Flowability

Chewable tablets must have an acceptable flow rate. Any decreases in its flowability can eventually lead to drastic alterations of the physical–chemical parameters of the chewable tablets. As such, excipient selection is extremely important in the development of chewable tablets so as to maintain an acceptable flow rate.

Q4. What are the general excipients used in the formulation of chewable tablets?

Functional excipients are often selected to help achieve the desired mouth feel and mask the bitter or unpleasant taste of chewable tablets. However, selecting the correct excipients is also important for other critical functions such as disintegration and lubrication. Some general excipients used in the formulation of chewable tablets or chewable supplements are noted below.

Diluents

Diluents are added to chewable tablet formulations to increase the bulk volume of the tablet. Diluents may also facilitate drug absorption and/or solubility enhancement, aid in the handling of APIs (Active Pharmaceutical Ingredients), prevent degradation, etc. Diluents commonly used in the formulation of chewable tablets include mannitol, sorbitol, dextrose, lactose, sucrose, etc.

Flavoring Agents

Flavoring agents are generally used to improve the desirable characteristics of taste, texture, and overall palatability of formulations. Taste is almost certainly the most important parameter in the evaluation of chewable tablets, therefore flavouring agents are key excipients of chewable tablet formulations. Flavoring agents include sweetening agents, flavored syrups, aromatic oils, synthetic flavors, etc.

Disintegrants and Superdisintegrants

Disintegrants or disintegrating agents are added to formulations to overcome cohesive strength imparted during compression, thus facilitating the breakdown of the chewable tablet into granules for ready drug availability once they come in contact with moisture.

Superdisintegrants are another version of super-absorbing materials with tailor-made swelling properties. Superdisintegrants are used to improve the efficacy of solid dosage forms. They increase the performance of the chewable tablet by decreasing its disintegration time.

Lubricants

Pharmaceutical lubricants are the agents added to tablet and capsule formulations in a very small quantity to improve their powder processing properties. For chewable tablet formulations, coated particles are blended with fillers, disintegrants, and lubricants prior to tableting.

Colorants or Coloring Agents

Colorants or coloring agents are like cosmetics for pharmaceutical preparations. Colorants are used in chewable tablets to increase aesthetic appeal, to mask non-uniform colors of raw materials, and to aid in product identification and differentiation amongst other reasons.

Q5. Which are the leading pharmaceutical companies offering CDMO services for chewable tablets?

Some leading Contract Development and Manufacturing Organizations or CDMOs for chewable tablet formulation development including trilayer and bilayer chewable tablets, chewable supplements and mini-tablets along with other chewable products and pediatric dosage forms are noted below.

Adare Pharma Solutions - CDMO for Chewable Tablet Formulation Development

Adare is a global, technology-driven Contract Development and Manufacturing Organization (CDMO) for product development through full-scale commercial production or commercial manufacturing expertise focused on oral formulations. Adare also offers CDMO services for the development of pediatric products or pediatric dosage forms.

Microcaps, delivering a smooth, pleasant mouthfeel, are available as chewable tablets, stick packs, sprinkles, orally disintegrating tablet (ODT) or oral disintegrating tablets (ODTs), etc. Adare provides CDMO services for chewable tablets and thus functions as a CDMO for chewable tablets. Adare also offers controlled release tablets, immediate release tablets, modified release formulations such as mini-tablets, nutraceutical commercial products, etc.

Pierre Fabre - Contract Development and Manufacturing Organization (CDMO) for Lozenges

Pierre Fabre CDMO offers commercial services which cover the sourcing of raw materials, the industrial production of plant-based, animal-based or synthetic active ingredients, for the pharmaceutical, cosmetics and nutraceutical sectors.

Pierre Fabre CDMO offers manufacturing services and packaging for lozenges made from hard boiled sugar (pharma status, dietary chewable supplements, medical devices) and conventional dry oral formulations (tablets, capsules, powder sachets).

Ascent Innovative Medicines - Full-service Provider Offering Chewable Tablets

Accent is a full-service provider that offers end to end pharmaceutical formulation development of chewable tablets ranging from early phase development to clinical supplies of clinical trial materials for new chemical entities, generics and life cycle extension products. They also offer immediate release tablets, modified release formulations such as controlled release tablets, orally disintegrating tablet (ODT) or oral disintegrating tablets (ODTs), etc.

Sushen Medicamentos Pvt. Ltd - Chewable Tablet Formulation Development

Sushen Medicamentos is a global full-service provider of end-to-end commercial services with a focus on drug delivery research and pharmaceutical product development. Sushen’s expertise can bring a complex formulation project into clinical and bioequivalence with superior quality and innovative solutions.

Sushen’s commercial product portfolio includes immediate release tablets, modified release formulations such as controlled release tablets, orally disintegrating tablet (ODT) or oral disintegrating tablets (ODTs), chewable tablets, mini-tablets, etc. Sushen therefore functions as a CDMO for chewable tablets. It also offers manufacturing services for the production of clinical trial materials.

Zenvision Pharma LLP - Chewable Tablet Development

Formulation Development is the core activity at Zenvision Pharma and it includes pre-formulation studies, formulation development, analytical method development and validation, dossier preparation and technology transfer. Its service offerings include chewable tablet development. Additionally Zenvision offers commercial services, manufacturing services, clinical support such as stability studies and analysis of clinical trial materials, etc.

Patheon by Thermo Fisher Scientific - Trilayer and Bilayer Chewable Tablets

Thermo Fisher Scientific provides industry-leading pharma services solutions for drug development, clinical trial logistics and commercial manufacturing to customers through its Patheon brand. Patheon offers immediate release tablets, sustained release tablets, multi-therapies (bilayer, trilayer and bilayer chewable tablets, capsules), solubility enhancement, taste masking, etc.

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