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Overview of cream, lotion, ointment, gel & hormonal products for topical drug delivery offered by leading pharma contract manufacturers (CMOs).
Q1. What is topical drug administration and what are the different types of topical dosage forms?
Topical drug administration refers to the application of topical dosage forms to the surface of the skin or mucous membrane of the eye, ear, nose, mouth, vagina, etc. with the intent of containing the pharmacological effect of the drug only to the surface or within layers of the skin or mucous membrane.
Drug delivery of topical formulations via the skin is becoming progressively popular due to its convenience and affordability. The skin is the most important mechanical barrier to the penetration of many drug substances and acts as an ideal site to deliver drugs, both locally and systemically.
The topical route of drug administration is used for the local treatment of skin, control of external and internal parasites, and transdermal delivery of therapeutic agents. Furthermore, topical formulations are made up in a vehicle, or base, which may be optimised for a particular site of the body or type of skin condition being treated.
Topical dosage forms include ointments, lotions, gels, pastes, and creams, among various other formulations. The rate of drug release from ointments, creams, lotions, gels, and pastes is principally determined by the semisolid base used in the formulation.
Some Common Topical Formulations
- Ointments
Ointments are semi-solid, water-free or nearly water-free (80% oil) preparations in which a drug is suspended or dissolved in a grease or oil base. They are thus greasy, sticky, emollient, protective, and occlusive, due to which application to hairy areas should be avoided.
Ointments may include a hydrocarbon (paraffin), wool fat, beeswax, macrogols, emulsifying wax, cetrimide or vegetable oil (olive oil, arachis oil, coconut oil). Other substances which may be used as a base include petroleum, liquid petroleum (mineral oil), olive oil, lanolin, and other animal fats.
- Creams
Creams are an intermediate preparation between wet dressings that dry skin lesions and ointments that keep lesions moist. Creams are semisolid, have a high percentage of water, are water-washable and don't leave a greasy residue after use as compared to ointments.
Additionally, creams absorb fluids from the skin and spread so easily that any medication dissolved in the cream comes in good contact with the skin. Cream formulations require preservatives to extend its shelf life.
- Gels
Gels are semisolid dosage forms that contain a gelling agent (often cellulose) to provide stiffness to a liquid solution or colloidal dispersion for external application to the skin. Gels are transparent preparations which liquify on contact with the skin, dry, and leave a thin film of active medication. Gels also often include preservatives and fragrances.
- Lotions
Lotions are liquids, usually aqueous or sometimes alcoholic preparations, containing insoluble material in the form of a suspension or emulsion, intended for external application without rubbing for skin conditions such as itching, infection, allergy, pain, etc.
Some Advantages of Topical Drug Administration
- Useful for local delivery of agents, particularly those which have toxic effects if administered systemically.
- Avoidance of first pass metabolism.
- Selective drug delivery to specific sites, convenient to use and easy to apply, suitable for self-medication, better patient compliance, and easy termination.
- Gastro-intestinal incompatibility avoidance.
- Avoidance of the risks and inconveniences of administration and the varied conditions of absorption, like pH changes, presence of enzymes, gastric emptying time, etc. in enteral or parenteral routes.
- Provides effectiveness in low doses and by continuous drug input, avoids fluctuation in drug levels and risks.
- Improved physiological and pharmacological response.
- Larger area of application compared to other routes.
Q2. What are hormonal gels and creams?
A hormone is defined as a chemical released by a cell or a gland in one part of the body that sends out messages that affect cells in other parts of the organism. Only a small amount of hormone is required to alter cell metabolism.
Hormones regulate growth, sex drive, sexual development, reproduction, sexual function, metabolism, and thirst among other things. Additionally, hormones are integral to our digestive, immune, urinary, reproductive, nervous, cardiovascular, respiratory and skeletal systems.
Hormonal formulations are drug products with a mixture of active ingredients (APIs), specifically hormones, along with other inactive components that elicit a therapeutic response upon administration. For example, hormone therapy, used to treat cancers, are used to block hormones or their actions.
There are numerous hormonal formulations including hormonal tablets, capsules, liquids and injectables. Hormonal preparations such as hormonal gel and solutions and hormonal creams are also available in the market.
Hormonal Products - Hormonal Gels & Hormonal Creams
Hormonal Products - Gels
A gel is a solid or semisolid system of at least two constituents, consisting of a condensed mass enclosing and interpenetrated by a liquid. Topical gel formulations provide a suitable delivery system for drugs because they are not very greasy and can be easily removed from the skin.
Hormonal gels are semi-solid drug delivery systems in which the active ingredient or mixture of active ingredients are composed of hormones. These are the agents that elicit a therapeutic response for the medical indication being treated. Some examples of hormonal preparations in gel form include estradiol gel, testosterone gel, oestrogen gel, etc.
Hormonal Products - Creams
Creams are viscous semi-solid emulsions for external use. A cream may be a water-in-oil or oil-in-water emulsion, depending on the emulsifying agent used. They are intended to be applied to the skin or certain mucous membranes for protective, therapeutic, or prophylactic purposes.
Hormonal creams are semi-solid drug delivery formulations or semi solid drug delivery systems in which the active ingredient or mixture of active ingredients are composed of hormones. These hormonal preparations are the agents that elicit a therapeutic response upon administration. Some examples of hormonal preparations in cream form include estrogen cream, progesterone cream, etc.
Various Contract Manufacturing Organizations (CMOs), CDMOs, etc. offer services for contract manufacturing hormonal cream formulations and contract manufacturing hormonal gel and solutions.
By outsourcing services for contract manufacturing hormonal gels and contract manufacturing hormonal cream products, one can ensure that clinical and commercial cGMP manufacturing goals are met.
Outsourcing services for contract manufacturing hormonal gel and contract manufacturing hormonal cream products can be beneficial as the manufacture of these hormonal semisolid dosage forms is very complex. Furthermore contract manufacturing hormonal cream and contract manufacturing hormonal gel formulations can reduce costs and time to market.
Q3. What are the quality factors influencing commercial manufacturing of semi-solid dosage forms?
Semi-solid dosage form manufacturing and semi-solid dosage form development requires specialized production techniques to assure high-quality results. Some of the quality factors influencing GMP bulk manufacturing of semisolid dosage forms are noted in detail below.
Some Physical Properties Affecting Quality
- Homogeneity
Homogeneity is the state of being all of the same kind. Homogeneity is important, because semisolids involve more than one phase, and all phases must be properly blended to achieve the desired result. The API as well as all excipients and other ingredients, must be uniformly distributed throughout the mixture. Proper homogeneity produces even distribution of medication in ointments, gels and creams.
- Particle Size Distribution (PSD)
Particle size also plays a key role in topical semi-solid drug delivery as it determines the product’s pharmacologic properties. For instance, if the API is suspended in a vehicle such as a cream or gel, the particle size will interact with the vehicle’s solubility to dictate the dissolution rate. Particle Size Distribution (PSD) also impacts the depth, rate, and pathway of absorption through the skin.
- Spreadability
Semisolid drugs must also exhibit appropriate spreadability to ensure that the desired therapeutic effect is achieved, because spreadability determines the distribution of the API over the area to which the semisolid is applied. Poor spreadability can lead to patient dissatisfaction.
- Surfactants
Surfactants are the most common inactive ingredients used in topical drug products. Surfactants in topical products play many functional roles such as emulsifiers, permeation enhancers, and solubilizers. Proper surfactant use enables the formation of emulsions and suspensions of oil and aqueous phases and is crucial to achieving stable formulations.
Other Factors Affecting Quality
- Equipment
Proper equipment is equally important as correct formulation in the manufacture of quality semi-solid pharmaceutical dosage forms. Mixers, emulsifiers, jackets, tanks, agitators, mills and other equipment are integral to the GMP bulk manufacturing process and must function at high efficiency for desired results.
- Testing
Monitoring the quality of drug products requires physical, microbiological and chemical testing throughout dosage form development and GMP bulk manufacturing of semi-solids. Specific testing of semi-solid formulations maintains quality control and prevents unfavorable results.
- Packaging and Storage
Maintaining proper packaging and storage conditions is crucial for the production of quality semi-solid products. Storage of semisolids should be at temperatures not exceeding 25° unless otherwise authorized as temperature variations can result in the degradation of gels, creams, ointments, etc.
They should also not be allowed to freeze and must be stored in a well-closed container or, if the preparation contains water or other volatile ingredients, they should be stored in an air-tight container.
Q4. Which are the leading pharmaceutical companies offering contract services for semi-solid dosage forms?
Various Contract Manufacturing Organizations (CMOs) and CDMOs offer contract development and pharmaceutical contract manufacturing services for semi-solid drug products.
This includes contract manufacturing for topical semi-solids such as creams (e.g. contract manufacturing hormonal cream), gels (e.g. contract manufacturing hormonal gel), lotions, liquid solutions, ointments, and pastes, along with other novel drug delivery systems.
Leading Contract Manufacturing Organizations (CMOs), CDMOs offering contract manufacturing for topical semi-solid pharmaceutical dosage forms are noted below.
Fermion Oy - Semi-solid Manufacturing of Cream and Ointments
Fermion, through its mother company Orion, is an experienced manufacturer of several dosage forms that offers contract manufacturing for topical semi-solid pharmaceutical drug products. They manufacture creams, ointments, liquids, hormonal gels and solutions, tablets, capsules, dry powder inhalers, etc. for global markets.
Mission Pharmacal - Semi Solid Dosage Form Manufacturing
Mission Pharmacal manufactures a variety of pharmaceutical products and offers leading-edge capabilities and technologies. Using the latest high-capacity equipment it manufactures and specializes in creams, gels, liquids and tablets.
Polpharma - Topical Pharmaceutical Contract Manufacturing Services
Polpharma offers contract services including pharmaceutical contract manufacturing services for various topical and semisolid dosage forms such as gels, emulsions and ointments. It offers clinical and commercial cGMP manufacturing for semi solid dosage forms.
Recipharm AB - Semi-solid Formulation Development & Contract Manufacturing for Topical Semi-Solid Pharmaceutical Dosage Forms
Recipharm is equipped to take on semi-solid formulation development and semi-solid manufacturing (clinical and commercial cGMP manufacturing) projects. General APIs, as well as corticosteroids and controlled drugs, are handled within Recipharm's semi-solid dose manufacturing facilities for the commercial manufacturing of semisolid dosage forms.
JGL d.d - Pharmaceutical Contract Manufacturing and Packaging for Semi-solids
JGL manufactures various semi-solid dosage forms such as ointments, creams and gels along with liquid solutions, in the form of an aluminium or plastic tube. The filling process and packing is done by simply switching between different formats.
It offers clinical and commercial cGMP manufacturing for semi solid dosage forms. JGL also offers various solids and liquids in addition to semi-solid dosage forms.
Eurofins CDMO - Semi-solids
Eurofins CDMO offers drug formulation development contract services encompassing preclinical contract development, formulation screening and dosage form development, and analytical contract development of semi solid dosage forms for skin, mucosal or oral delivery.
Madras Pharmaceuticals - Contract Manufacturing for Topical Semi-Solid Pharmaceutical Drug Products
Madras Pharmaceuticals offers various topical dosage forms such as cream, ointment, gel along with other solid and liquid dosage forms like tablets, capsules, dry powder for suspensions, syrups, etc. It offers commercial manufacturing of semisolid dosage forms.
Grunenthal - Cream / Lotion / Ointment Pharmaceutical Contract Manufacturing and Packaging
Grunenthal's Tecnandina S.A. offers pharmaceutical contract manufacturing and packaging services. It is the largest and most modern manufacturing plant that can offer commercial manufacturing of semi solid dosage forms.
It offers a variety of formulations such as granules, coated tablets, capsules, liquids, semi solid dosage forms and packaging in various blister, sachet or bottle forms.
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