Contract Manufacturing | Oral Liquids

Looking for syrup drug products? Find a CMO offering oral liquids, such as syrup, oral suspension & other pharmaceutical formulations on PharmaCompass.

Q1. What are syrups and what are the different types?

Syrup is a concentrated or nearly saturated solution of sucrose or sugar substitute in water with or without flavoring agents and medicinal substances. The concentration of sugar in syrup is 66.7 % w/w. Syrup, also includes any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions. Syrups may be medicated or non-medicated (flavoured syrups). The non-medicated syrup is intended as a vehicle or flavor in pharmaceutical preparations.

For providing temporary relief to patients in case of sneezing, coughs, runny noses which are commonly caused by cold, high fever, or allergies, cough syrups are used from ancient times. Moreover, the rising geriatric population, which is more susceptible to such ailments, is providing a thrust to market growth. Some of the leading syrups manufacturers or syrups contract manufacturers offering pharmaceutical contract manufacturing services for dry and liquid syrups and other liquid orals for commercial purposes are explored ahead.

There are various types of syrups which are noted below:

Simple Syrup - When purified water alone is used in making the solution of sucrose, the preparation is known as syrup, or simple syrup. Hence, these are sugar-based syrup, which are concentrated solutions of sucrose.

Artificial Syrup: These syrups are formulated with artificial sweetening agents and viscosity builders. These are also called flavored syrups. These syrups contain pleasantly flavored substances but not medicinal substances, hence called non-medicated syrups or flavored syrups e.g. cherry, acacia, and raspberry syrup. It is intended as a vehicle or flavor for preparations.

Medicated Syrup - Pharmaceutical syrups contain an active pharmaceutical ingredient (API) known as medicated syrup, e.g. cough syrup. In these syrups, there are always therapeutic compounds added (e.g. guaifenesin syrup).

There are two types of medicinal syrup. One is made from extractive drugs where fluid extract of the respective medicines is mixed with the syrup and the other is made up of chemicals which can be either a simple solution or a chemical reaction used to modify the taste of medicinal agents.

Classification of pharmaceutical syrups based on their basic formula:

Sugar-Based Syrups – Although there are many different sugars, but sucrose and dextrose are widely used in the preparation of syrup.

Sugar-Free Syrups - These syrups contain artificial sweeteners. These are intended as a substitute for sugar-based syrups and are intended to be administered to persons who must regulate their sugar and calorie intake.

Q2. What are the benefits of pharmaceutical syrups over other dosage forms?

There are various benefits of pharmaceutical syrups over other dosage forms which are mentioned below:

- Pharmaceutical syrups are appropriate for any patient, whatever the age is.

- Syrups are better for patients who have trouble swallowing.

- No nursing is required for the administration of pharmaceutical syrups, which means the patient can take it with no help.

- They are attractive in appearance and give beneficial psychological effects.

- Syrup dosage form is preferred for certain types of products like cough medicines.

- Drugs with bitter and unpleasant taste can be given in sweetened, coloured and flavored vehicles.

- It is the best choice for geriatric and pediatric patients.

- Syrup retards oxidation because it partly hydrolyzes into dextrose and levulose (reducing sugary). Hence it prevents decomposition of many substances and no preservative is needed against the growth of micro-organisms such as bacteria, molds, fungi, etc.

- Syrups come in tamper-proof packaging to prevent spillage and damage during transit.

Pharmaceutical contract manufacturers that may have experience and expertise in oral pharmaceutical formulation development and manufacturing may offer pharmaceutical syrup contract manufacturing services along with services for liquid orals such as solution, oral suspension, elixirs, etc. from development to commercialization.

Q3. What are the key ingredients of pharmaceutical syrup formulations and what are the different steps involved in the manufacturing of syrups?

When developing and manufacturing pharmaceutical syrups, consideration is first given to the characteristics of the active pharmaceutical ingredient. Most pharmaceutical syrups contain the following components in addition to purified water and active pharmaceutical ingredient(s).

Sugar - Usually sucrose and other substitutes are added for sweetness and viscosity. There are various sugar-free alternatives available such as sorbitol, saccharine, aspartame, etc. Sucrose is one of the purest commercially available substances and is the preferred carbohydrate in the manufacturing of pharmaceutical syrup because of purity, degree of sweetness, lack of color and ease of handling.

Antimicrobial Preservatives - Syrup, USP is protected from bacterial contamination by virtue of its high solute concentration. But more dilute syrups are good media for microbial growth and hence require the addition of preservatives. Among the anti-microbial preservatives the most commonly used in syrups with the usually effective concentrations are benzoic acid 0.1-0.2%, sodium benzoate 0.1-0.2% and various combinations of methylparabens, propylparabens and butyl parabens, etc.

Flavors and Colorants - Flavours used in the syrup formulation must be non-toxic, soluble and compatible with the preparation.

Miscellaneous Agents - Syrups may also contain special solvents (including alcohol) solubilizing agents, thickening agents and stabilizers. A thickening agent or thickener is a substance which can increase the viscosity of the diluted syrups without substantially changing its other properties.Tween 20 emerges as solubilizer of choice for certain syrups.

There are various methods for the formulation of pharmaceutical syrups. Based on the physical and chemical properties of the active pharmaceutical ingredients (APIs), the choice of the method is selected.

Pharmaceutical syrups are produced by mixing purified water, sweeteners, active pharmaceutical

ingredients (API), aromas, flavours and other ingredients (thickeners, solubilizers). Traditional

cough syrups are formulated around a pharmaceutical syrup at 60-75% concentration which is made from sucrose, maltodextrin, glucose, invert syrup, etc.

The manufacturing process of syrups must achieve several functions:

- Dissolving of the sugars (sucrose, glucose, maltodextrin,sorbitol) in the appropriate solvent.

- Hydration of the powdered ingredients.

- Blending ingredients of widely different viscosity. Preparations should be heated before finishing the addition of components.

- Solid products are added by means of solid-liquid blenders or vacuum systems.

- Dissolving active pharmaceutical ingredients (APIs) with the help of solubilizing agents and solvents. A high shear mixer is used for mixing.

- When the process is finished, the end product is filtered (if required) and sent to the storage tanks. The end product must be smooth, agglomerate-free and homogeneous.

- The product is transferred from the storage tanks to the filling machines by pumps and finally packed into the bottles. All the manufacturing equipment should comply with the GMP standards.

There are a number of syrup pharmaceutical manufacturers which can offer contract manufacturing services for medicated and flavoured syrups. These liquid oral dosage forms can be outsourced from CDMOs offering pharmaceutical contract manufacturing services for oral solids and oral liquids such as oral suspension, syrup, solutions, elixirs, etc.

Q4. Which are the leading companies offering pharmaceutical syrup contract manufacturing services?

Various pharmaceutical organizations, such as a contract development and manufacturing organization (CDMO) and contract manufacturing organization (CMOs), pharmaceutical contract manufacturers can offer end-to-end pharmaceutical formulation development and manufacturing services for oral liquids, including syrup, suspension, solutions, elixirs, etc.

Some of the top syrups contract manufacturers offering dry and liquid syrups for clinical and commercial purposes are mentioned below.

Polpharma- Pharmaceutical Syrup Contract Manufacturing Services

Polpharma offers customized contract manufacturing of various liquid dosage forms such as oral liquids, syrups, suspensions and solutions. Its pharmaceutical plant at SANTO has a complete modern production cycle of oral solid dosage forms (capsules, granules, sachets), oral liquids (syrups), solutions for internal and external use, etc.

Temad Co- Third Party Contract Manufacturing for Pharmaceutical Syrups

Temad deals in the production of finished dosage products including various kinds of syrups, tablets and capsules. It is one of the top syrup pharmaceutical manufacturers and with a production line for oral solutions (syrup) which is licensed to produce methadone syrups, opium and guaicodin in its product line.

Madras Pharmaceuticals -Pharmaceutical Contract Manufacturing Services

Madras Pharma offers pharmaceutical contract manufacturing for syrups and has capabilities to offer liquid orals, including oral suspension, solution and micro-emulsion, external semi-solids (cream, gel, ointment, lotions), medicated dusting powders and lyophilised injections, etc. It is one of the leading syrups contract manufacturers with seven state-of-the-art world-class manufacturing facilities equipped with ultramodern plants and machineries for manufacturing of a wide variety of formulations.

Grunenthal- Pharmaceutical Third Party Manufacturing Services

Grunenthal is one of the leading syrups manufacturers that offers pharmaceutical third party manufacturing services for semi-solid and liquid pharmaceutical forms, including, creams, ointments, gels, lotions, sterile ampoules, syrups, suspensions, etc. It is one of the leading pharmaceutical contract manufacturers and their Latin American site is the primary manufacturing site for supply of solid, semi-solid and liquid products.

Pierre Fabre- Third Party Contract Manufacturing for Pharmaceutical Syrups

Pierre Fabre CDMO is among the leading syrup pharmaceutical manufacturers that offers complete services, from pharmaceutical formulation to commercial manufacturing for non-sterile liquids (syrups and sprays) and paste forms (creams, ointments, gels), etc. The Pierre Fabre group offers pharmaceutical and non-pharmaceutical subcontracting activities (CDMO) which combine a high level of quality, skill and performance.

Fareva- Third Party Contract Manufacturing

Fareva offers pharmaceutical third party manufacturing services for syrups, injectables, creams, ointments, granules, capsules, gels, suppositories, etc. It is one of the leading syrups manufacturers which offers various other pharmaceutical forms, including suspensions, emulsions, powders, lyophilised products, syringes (PFS), etc.

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