Formulation of Specialty Tablets for Slow Oral Dissolution

Introduction

 Dosage forms that dissolve slowly in the mouth, or that can be easily chewed and
Swallowed, are gaining in popularity, especially among pediatric patients.

 Hard (compressed or molded) preparations of this dosage form are called lozenges,
troches or drops.

 Soft (molded) lozenges/troches are often called pastilles, and chewable, gelatin based
Lozenges/troches are often called gummy, novelty-shaped products.

 Lozenges are solid preparations that are intended to dissolve or disintegrate slowly in
the mouth. They contain one or more medicaments, usually in a flavored, sweetened
base.They can be prepared by molding (gelatin and/or fused sucrose or sorbitol base) or
by compression of sugar-based tablets. Molded lozenges are sometimes referred to as
pastilles while compressed lozenges are often referred to as troches.

 They are usually intended for treatment of local irritation or infections of the mouth or
throat but may contain active ingredients intended for systemic absorption after
swallowing.

 Molded lozenges have a softer texture because they contain a high percentage of
sugar or a combination of a gelatin and sugar.

 Hard lozenges have hard candy bases made of sugar and syrup and often incorporate
an adhesive substance such as acacia.

 Commercial lozenges are made on a tableting machine using high-compression

pressures. Ingredients should be heat stable if they are to be incorporated into
compounded lozenges.

 Recently, soft lozenges and chewable lozenges have been reintroduced into
pharmacy and are enjoying increased popularity.

 Soft lozenges generally have a polyethylene glycol (PEG) base, whereas chewable
lozenges have a glycerinated gelatin base. These dosage forms usually are chewed and
are a means of delivering the product to the gastrointestinal tract for systemic
absorption.
Composition

1. Hard Lozenges

 Hard candy lozenges are mixtures of sugar and other carbohydrates in an

amorphous (noncrystalline) or glassy condition.

 These lozenges can be considered solid syrups of sugars and usually have a
moisture content of 0.5%–1.5%.

 Hard lozenges should not disintegrate but instead provide a slow, uniform
dissolution or erosion over 5–10 minutes. They should have a smooth surface
texture and a pleasant flavor that masks the drug taste.

 Disadvantage - high temperature required for preparation.

 Hard candy lozenges generally weigh between 1.5 and 4.5 g.

 Excipients such as sorbitol and sugar have demulcent effects, which relieve the
discomfort of abraded tissue caused by cough and sore throat.

2. Soft Lozenges

 The bases usually consist of a mixture of various PEGs, acacia, or similar materials.

 Older form of soft lozenges - pastille, which is a soft lozenge, is usually transparent, and
consists of a medication in a gelatin, a glycerogelatin, or an acacia: sucrose base.

 These lozenges may be colored and flavored and they can be either slowly dissolved in
the mouth or chewed, depending on the intended effect of the incorporated drug.

3. Chewable Lozenges (Gummy, Novelty-Shaped Products)

 Chewable lozenges are highly flavored and frequently have a slightly acidic taste.
Because their fruit flavor often masks the taste of the drug, they are an excellent way of
administering drug products.

 Chewable lozenges are especially useful for pediatric patients and are an effective
means of administering medications for gastrointestinal absorption and systemic use.

Preparation

 Lozenges are prepared by molding a mixture of carbohydrates to form hard candies, by

molding a matrix to form a soft lozenge or by molding a gelatin base into a chewable
mass.
  Hard lozenges are usually prepared by heating sugar and other components to a
proper temperature and then pouring the mixture into a mold or by pulling the mass out
into a ribbon while it cools and then cutting the ribbon to the desired length. A commercial
method is to compress the materials into a very hard tablet.

 Both soft lozenges and chewable lozenges are usually prepared by pouring a melted
mass into molds.

 Another method, which depends on the ingredients, involves pouring the mass out to
form a sheet of uniform thickness and then punching out the lozenges by using a punch of
the desired shape and size.

 Molds used in the preparation of lozenges must be calibrated to determine the weight of
the lozenge using the applicable base. The calibration can be done as follows:

1. Confirm that the cavities of lozenge mold are clean and dry.
2. Obtain and melt sufficient lozenge base to fill 6–12 molds.
3. Pour it, cool and trim if necessary.

In general, the quantity of flavoring agent added to medicated lozenges is about 5–10 times that
used in candy lozenges to compensate for the flavor of the medication. If the flavoring agent (an
oil) is immiscible with the base, it can be dissolved in glycerin; the glycerin solution is then
incorporated into the product.

Applications:

Ambroxol lozenges-Anesthetic for sore throat

Flurbiprofen lozenges- Anti-Inflammatory for sore throat

BCoG lozenges (containing bacitracin, clotrimazole and gentamicin)- Antimicrobial lozenges

xylitol lozenges- prevent dental caries.