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Study of Natural Excipients in Semi-Solid Dosage Forms

Review Article | DOI: https://doi.org/10.31579/2690-8808/245

Study of Natural Excipients in Semi-Solid Dosage Forms

  • A. Krishna Sailaja *
  • Bayya Hrushitha
  • Bandra Ausha
  • Chinthakunta Deepika Reddy
  • Kommireddy Tejaswini

Department of Pharmaceutics, RBVRR Women’s college of Pharmacy, Hyderabad.

*Corresponding Author: A. Krishna Sailaja, Department of Pharmaceutics, RBVRR Women’s college of Pharmacy, Hyderabad.

Citation: A. Krishna Sailaja, Bayya Hrushitha, Bandra Ausha, Chinthakunta Deepika Reddy, Kommireddy Tejaswini, (2025), Study of Natural Excipients in Semi-Solid Dosage Forms, J, Clinical Case Reports and Studies, 6(2); DOI:10.31579/2690-8808/245

Copyright: ©, 2025, A. Krishna Sailaja. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Received: 10 February 2025 | Accepted: 18 February 2025 | Published: 25 February 2025

Keywords: semi-solid dosage forms; excipients; natural excipients

Abstract

A significant proportion of pharmaceutical dosage forms are semi solid preparations. They serve as carriers for drugs that are topically delivered by way of the skin, cornea, rectal tissue, nasal mucosa, vagina, buccal tissue, urethral membrane, and external ear lining. This data collection's goal is to give readers a comprehensive understanding of the different tools, tactics, crucial process variables, and production and validation procedures processes specific to semisolid dosage forms.

Introduction

Typically, topical semisolid dose forms are in the shape of pastes, ointments, gels, or creams. The ease of use, quick formulation, and capacity to topically administer a broad range of drug molecules are all benefits of a semisolid dosage form. There are many different dose forms for semisolids, and each has special qualities. In addition to any appropriate excipients, such as emulsifiers, viscosity-increasing agents, antimicrobial agents, antioxidants, or stabilizing agents, they comprise one or more active substances that have been dissolved or evenly distributed in an appropriate base.

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Figure 1: Semi solid dosage forms

Advantages for semi solid dosage forms:

  • It is used externally
  • Probability of side effect can be reduced
  • Local action
  • First pass gut and hepatic metabolism is avoided.
  • Patient compliance is increased, the drug termination is problematic cases is facilitated as compared with other routes of drug administration [1]
FormulationDescription
OintmentsOintments are homogenous, semi-solid preparations intended for external application to the skin or mucous membrane.
CreamsCreams are homogeneous, semi-solid preparations consisting of opaque emulsion systems.
GelsGels are usually homogeneous, clear, semi-solid preparations consisting of a liquid phase within a three-dimensional polymeric matrix with physical or sometimes chemical cross-linkage by means of suitable gelling agents.
PastesPastes are homogeneous, semi-solid preparations containing high concentrations of insoluble powdered substances (usually not less than 20%) dispersed in a suitable base
PoulticeA poultice is an ancient form of topical medication also known as a cataplasm. It is a soft mass of vegetable constituents or clay, usually heated before application.[2]

Table 1: Types of semi-solid dosage forms

Ointment: Ointments are homogenous, semi-solid preparations intended for external application to the skin or mucous membrane. They are used as emollients or for the application of active ingredients to the skin for protective, therapeutic, or prophylactic purpose and where a degree of occlusion is desired.

Advantage of ointments as a dosage forms:

  •   Inexpensive
  •   Nonreactive
  •   Non-irritating 
  •  Good emollient, protective, and occlusive properties
  •   Not water-washable so they stay on the skin and keep incorporated medications in contact with the skin[2]
Emulsifying agentCotton seed oil, Paraffin wax, Beeswax, Palm oil
HumectantsPropanediol, vegetable glycerine, honey, marine collagen
PreservativesClove oil, Neem oil, Cumin seeds, Cayenne pepper
AntioxidantsPeppermint, Rosemary, Cinnamon, Saffron
Oleaginous basesCastor oil, Lanolin, Mineral oil, Sunflower oil [3]

Table 2: Excipients used in ointments

OINTMENT BASES: The vehicle or carrier of an ointment is known as ointment base. The choice of ointment base depends upon the nature of medicament, stability of ointment and clinical indication of the ointment. [4]

PropertyOleaginous compounds Oleaginous bases + w/o surfactant Oleaginous base + water Polyethylene glycol 
Water content Anhydrous Anhydrous hydrous Anhydrous hydrous 
Affinity for water Hydrophobic Hydrophilic Hydrophilic Hydrophilic 
Spread ability Difficult Difficult Easy Moderate- easy 
Washability Non washable Non washable  washable  washable 
Stability Oils poor, hydrocarbon betterOils poor, hydrocarbon better Unstable especially alkali soap and natural colloids Stable 

Table 3: Properties of different ointment bases

 Ideal properties of Ointment bases

  •  Chemically and physically stable under normal conditions of use and storage 
  •   Nonreactive and compatible with a wide variety of drugs and auxiliary agents 
  •   Free from objectionable odor 
  •  Nontoxic, non-sensitizing, and nonirritating  
  • Aesthetically appealing, easy to apply, and nongreasy 
  • Remains in contact with the skin until removal is desired, then is removed easily [5].
Excipient BS Family Synonym Use Formulation 
Castor oil It is obtained from seeds of Ricinus communis Euphorbiaceae Ricinoleic acid Ointment base Topical ointments
Sunflower oilIt is obtained from fruits and seeds of Helianthus annus Compositae

Helianthus annus oil

Oleum helianthin

Ointment baseSkin creams Lotions
Mineral oil It is a mixture of refined liquid saturated aliphatic and cyclic hydrocarbons obtained from petroleum 

Heavy mineral oil, 

Liquid petroleum 

Ointment base 

Opthalmic formulations, 

Transdermal contraceptive patches, Suppositories 

Lanolin It is obtained from wool of sheep, Ovis Aries linn Bovidae Refined wool fat Ointment base 

Creams, Ointments, 

Suppositories [ 6]

Table 5: Details of various natural oils as excipients in semi-solid dosage forms

EMULSIFYING AGENT: Emulsions are liquid disperse systems consisting of two immiscible phases, one of which is dispersed as globules in the other liquid phase [7]. The two phases of emulsions are stabilized by the presence of an emulsifier. The droplet diameter of the dispersed phase extends from about 0.1 to 10 μM, although particle diameters as small as 0.01 μM and as large as 100 μM are not uncommon. The consistency of emulsions ranges from that of a liquid (e.g., fat emulsions) to a semisolid (e.g., ointments and creams]

Ideal properties of natural emulsifying agents:

  •  Emulsions exhibit all of the properties of a colloidal solution, including Brownian movement, Tyndall effect, and electrophoresis.
  • The addition of electrolytes containing polyvalent metal ions coagulates the globules, demonstrating their negative charge.
  • In emulsions, the size of the dispersed particles is bigger than in sols. It has a range of 1000 to 10,000 Ă. The size, on the other hand, is less than that of particles in suspensions
Excipient        BS     Family  Synonym          Use Formulation 
Soybean oilIt is  extracted from seeds of soybean plant(Glycine max) Fabaceae Soy oilEmulsifying agentCreams
Paraffin waxParaffin wax is manufactured by distillation of crude petroleum or shale oil.   Paraffin durumEmulsifying agentointments
BeeswaxBees wax is obtained from the honey comb of the beeApidae.Cagesoft, Dynasanp60

 

 Emulsifying agent

Ointments
Palm oilthe oil obtained from the pulp of the fruit of the oil palm Elaeis guineensis jacq Aceraceae.Cage soft Dynasanp60Emulsifying agent

Creams Ointments

[8]

Table 6: Details of various natural emulsifying agents as excipients in semi-solid dosage forms

HUMECTANT: these are an important group of cosmetic ingredients and will be found in most skin care products that contain an aqueous phase. Humectants moisturise the skin in a unique way. They attract water to the skin.[9]

Ideal properties of natural humectants:

  • Good odour and taste
  • Non-corrosive to packaging material
  • Non-toxic, non-irritant
  • compatible with other materials
  • Not solidify or crystallize at normal condition
Excipient       BS     Family  Synonym          Use Formulation 
Marine collagenDerived from fish collagen peptides    -Fish collagenHumectantCreams, serums
HoneyProduced by our little bee friendsApidae. MadhuHumectantOintments, Creams, Syrups
 Vegetable glycerine

Derived from plant sources,

glycerine is a thick sweet,

sticky liquid

    -GlycerolHumectant Ointments
 Propanediol  Derived from cane sugar    -    -HumectantLotions, Cleansers [10]

Table 7: Details of various natural humactants as excipients in semi-solid dosage forms

PRESERVATIVES: Preservatives are usually used to minimize the shelf life of several food products and pharmaceuticals. Preservatives are vital to avoid the alteration and degradation of microorganisms during storage. Particularly in those with greater water content [11]

Ideal properties of natural Preservatives:

  • It should not be irritant.
  •  To maintain product consistency.
  • To maintain palatability and wholesomeness.
  •  It should not be toxic.
  •  It should be stable (physically and chemically).
  • It should be compatible with all other ingredients
  • It should be acting as good antimicrobial agent
  •  It should be potent in action.
  • It should have higher shelf life 
Excipient       BS     Family  Synonym          Use Formulation 
Lemon oilExtracted from the peel of citrus limon fruit RutaceaeCitrus limon peel oilPreservativeShampoos Pastes
Neem oilFruits of azadirachta IndicaMeliaceae Margosa oilPreservativeShampoos, Creams
Cumin seeds  Seeds of Cuminum cyminum ApiaceaeNigellaPreservativeSuppositories
 Cayenne pepper  Fruits of piper nigrumpiperaceaeChilli pepperPreservative

Topical ointments

Creams [12]

Table 8: Details of various natural preservatives as excipients in semi-solid dosage forms

ANTIOXIDANTS: Antioxidants are substances which counteract free radicals and prevent the damage caused by them. These can greatly reduce the adverse damage due to oxidants by crumbling them before they react with biologic targets, preventing chain reactions or preventing the activation of oxygen to highly reactive products 

  • Ideal properties of natural Antioxidants: 
  • It should be stable
  • It should be effective in low concentration
  •  It should be compatible
  • It should be non-toxic [13
ExcipientBSFamilySynonymUseFormulation
CatechinIt is a flavonoid antioxidant found in many plants, fruits, and vegetables-FlavanolAntioxidantCreams
Wheat branIts comes from the outer layers of the wheat kernealGramineae

Cereal fiber

Dietary fiber

AntioxidantNano emulsions [14]
SaffronSaffron consists of the dried stigma of the flowers of the crocus bulb, crocus sativus Kesar, Jafrananti-oxidant.

Creams

lotions

Table 9: Details of various natural humactants as excipients in semi-solid dosage forms

Creams:

Creams consist of opaque emulsion systems and are semi-solid, homogenous formulations. The kind of emulsion—water-in-oil (w/o) or oil-in-water (o/w)—as well as the makeup of the solids in the internal phase determine their consistency and rheological characteristics. Creams are designed to be applied to the skin or specific mucous membranes for preventive, therapeutic, or protective reasons, particularly in situations where an occlusive effect is not required. Topical medicines that can be applied to the skin are called creams. "Viscose liquid or semi-solid emulsions of either the oil-in-water or water-in-oil type" dosage forms, with varying oil and water contents, are referred to as creams. [15]

Ideal Properties Of Creams

  • Inert
  • Stable
  • Smooth 
  • Compatible with the skin 
  • Non-irritating 
  • Should release the incorporated medicaments readily.

Types of skin creams:

They are separated into two categories: An oil-in-water (O/W) emulsion is one in which the oil is distributed as droplets throughout the aqueous phase, whereas oil-in-water (O/W) creams are made up of tiny oil droplets distributed in a continuous phase. Creams known as water-in-oil (W/O) are made up of tiny water droplets scattered across an oily layer. The emulsion is of the water-in-oil (W/O) type when the dispersed phase is water and the dispersion medium is oil.

Cream types based on its purpose, unique qualities, and emulsion type:

  •  Make-up cream (o/w emulsion): a) Vanishing creams. b) Foundation creams.
  •  Cleansing lotion (without emulsion), cleansing milk, and cleansing cream 
  •  Winter cream (without emulsion): a) Moisturising or cold cream. 
  •  General and all-purpose creams. 
  •  Massage and night creams.
  •  Skin protective cream. 
  • Hand and body creams.[16]
Thickening agentAgar, Guar Gum, Xanthan Gum, Carrageenan
Emulsifying agentCotton seed oil, Paraffin wax, Beeswax, Palm oil
PreservativesClove oil, Neem oil, Tea tree oil, Ginger oil
AntioxidantsPeppermint, Rosemary, Cinnamon, Saffron

Table 10: Excipints Used In Creams:

Thickening agent:

A thickening agent, sometimes known as a thickener, is a material that can raise a liquid's viscosity without significantly altering its other characteristics. In addition to being used in paints, pigments, explosives, and cosmetics, edible thickeners are frequently used to thicken sauces, soups, and puddings without changing their flavour. Additionally, thickeners can 

enhance the suspension of other ingredients or emulsions, increasing the product's stability. 

Ideal properties of natural thickening agents:

It should have proper texture

Maintain consistence Temperature [17]

Excipient     BS      Family    Synonym    UseFormulation
AgarAgar is mainly extracted from species of Gelidium  amansii  GelidaceaeAgar-agar, agar gum, gelidium-amansiiThickening agentSuppositories
Guar gum Guar gum is obtained from the endosperm of the seeds of the guar plant Leguminosae Cyamopsis tetragonoloba gum, galactose gum, guaranThickening agent

Gels

Opthalmic preparations

 Xanthan gum Xanthan gum is obtained from the bacteria Xanthomonas campestris Pseudomonadaceaecorn sugar gum.

Thickening agent

 

 oral gels

Topical preparations

Carrageenan



 

Carrageenan as the hydrocolloid obtained by extraction with water or aqueous alkaliRhodophyceaeCapsulesThickening agentTopical products

Table 11: Details of various natural thickening agent as excipients in semi-solid dosage forms

Marketed formulations

Formulation  Company[Brand]   Dosage form      Excipient used
 Kumkumadi glowing creamhttps://lh7-rt.googleusercontent.com/docsz/AD_4nXct1OrLQGXh8Wp9m3jSP7_sL62R1oX0BYrdfwHEEL2ZWyAHErNHP7cXfUDRzBkXul8jmfcXp-Vs5fZLOXlEYm1yWES28f0pZkg8oO2SB3lvx1046H3AlgA1ZymeNW8PZCztgfOiW6iXTPqny8MokA?key=ugYkOL1JkVnnLGMKrvVUwO_1Khadi naturalSemi solid dosage formSaffron
Vegan lipstickshttps://lh7-rt.googleusercontent.com/docsz/AD_4nXfPHYX7Q8Eagrf0grw4vV6kONecfhNBlKryXWzbaWrnTRAfnXn4zO-Fl69yRzKyl87MIIIxF2q4eVgw1wqYhe1yEOp3CdFdkYwUfGqXInZD0VaQ2k_OwYDOfCS51w-QQuCxJIHMT87kEoWZq_Cimw?key=ugYkOL1JkVnnLGMKrvVUwO_1Blush-BeeSemi solid dosage formCochineal
Lanolin waxhttps://lh7-rt.googleusercontent.com/docsz/AD_4nXfWv2ZpbxEStofE4dwE-EcCWKmB6UWVoNz7JTlp53OaecYywD2UKcLuDW0QEJESjDIZjsZXlhVoiROZp37Y_m9imUBXM8BovT5JauHT5uvT-tC9u_yfww_5hP9SAezOrsxQMn_akhZDfPmPibEegw?key=ugYkOL1JkVnnLGMKrvVUwO_1Lodha petroSemi solid dosage formLanolin
Herbal lotionshttps://lh7-rt.googleusercontent.com/docsz/AD_4nXdAq9V-TuONM1ZSyBwkQvRilp_I8dw4N8ImVoVFH0FI8YXpdzPnZd52cTTCete2y9X4qR-3klfJlV2HW4iCyGCKafE988bpiwjdEHDx5_0jNdKxCYuS5kC74aG6pQ4VHGWcfIFmqeKrx_C2tsDXRCs?key=ugYkOL1JkVnnLGMKrvVUwO_1Baidyanath Semi solid dosage formMineral oil
Mustela Hydrating creamhttps://lh7-rt.googleusercontent.com/docsz/AD_4nXe2-SoiBnajkjZzNVvvPNR4sDIZFk2YvdqCyO3kFD2TtNrYeqd_SrIfmhPyf1D_Ombjedeb1PhSWix6ipuzRoridaU1ZWIhbBV6MrbMznA4QHcJyWRZ-5WQ6rcg2mDKd1zMWMw804DFVLj4AsJpt6A?key=ugYkOL1JkVnnLGMKrvVUwO_1Expanscience laboratoriesSemi solid dosage formSunflower oil
Locust bean gun ceratop lotionhttps://lh7-rt.googleusercontent.com/docsz/AD_4nXfvJf8vPmGOBs8CiEXXVn-u6oaN2VaW_AwNmIHDPhZ9iLgs5Bi4EnR0JK73Qv23MtTqP0brhSduydDRTgKeJMBoc5HYjb8NOQv1XDtDZB4RAdzDJPyOhvNUUrdql1Gq0DeYYAqUZonjcnCPGSqn464?key=ugYkOL1JkVnnLGMKrvVUwO_1Labh additivesSemi solid dosage formCeratonia

Conclusion:

Pharmaceutical excipients derived from natural sources have attracted a great attention in developing convectional dosage forms and novel drug delivery systems. The use of natural excipients is steadily increasing day by day due to the side effects of synthetic excipients. Hence natural excipients are being preferred over synthetic as they are cheap, biodegradable and enhance the bioavailability, stability, safety, efficacy and patient compliance. Therefore, there is going to be a great interest in natural excipients to obtain a better dosage form.

References

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