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Abstract

Pediculosis capitis is a common parasitic infestation caused by Pediculus humanus capitis, predominantly affecting school-aged children and posing significant social and hygienic concerns. Conventional treatments often suffer from drawbacks such as resistance development, skin irritation, and poor patient compliance. The present study focuses on the formulation and evaluation of a topical lotion intended for the effective management of pediculosis capitis with improved safety and acceptability. The lotion was formulated using suitable excipients to ensure optimal viscosity, spreadability, and ease of application on the scalp and hair. The prepared formulation was evaluated for various physicochemical parameters including appearance, pH, viscosity, homogeneity, spreadability, and stability under different storage conditions. Skin irritation studies were conducted to assess the safety profile of the formulation. Additionally, the pediculicidal efficacy of the lotion was evaluated through in-vitro and ex-vivo studies to determine its effectiveness against head lice. The results demonstrated that the formulated lotion possessed desirable physicochemical characteristics, remained stable during the study period, and showed no signs of skin irritation. The formulation exhibited significant pediculicidal activity, indicating its potential as an effective treatment option for head lice infestation..

Keywords

Pediculosis capitis, Head lice treatment, Pediculicidal agent, Ovicidal activity, Topical administration, Pediatric safety

Introduction

Pediculosis capitis, an infestation of the scalp by Pediculus humanus capitis, remains a common public-health concern, particularly among school-aged children worldwide.[¹] The close physical contact in crowded environments, sharing of personal items, and limited awareness of preventive measures contribute to its rapid transmission.[² ]Although not life-threatening, head lice infestation leads to intense pruritus, sleep disturbances, secondary bacterial infections, and significant psychosocial embarrassment..[³] Effective management is therefore essential to improve both personal health and community hygiene.Conventional pediculicides such as permethrin, malathion, and pyrethrins have been widely used; however, growing evidence shows decreased responsiveness due to resistance, skin irritation, and the need for repeated applications.[???] These challenges have encouraged researchers to explore safer, plant-based, and formulation-optimized alternatives. Herbal ingredients such as neem, tea tree oil, karanja oil, coconut oil, and camphor exhibit insecticidal, ovicidal, and soothing properties, making them promising candidates for anti-lice preparations. [?,?] Polyherbal formulations also offer synergistic action, improved efficacy, and reduced adverse effects. [?] Topical lotions are preferred dosage forms for head lice management because they provide uniform spreadability, ease of application, and prolonged contact time on the scalp, enhancing pediculicidal action. [ ¹? ]

Formulation factors—such as viscosity, emulsifier system, penetration enhancers, and stability—significantly influence the therapeutic performance of anti-lice products. [¹¹,¹³] Therefore, designing an optimized polyherbal lotion and evaluating its physicochemical properties and pediculicidal efficacy is an important step in developing and safe and effective results .[14]

The present study focuses on the formulation and evaluation of a polyherbal anti-lice lotion incorporating scientifically established plant-derived ingredients. The study aims to assess its physical characteristics, stability, and in-vitro pediculicidal potential for the effective management of pediculosis capitis.

MATERIALS            

The following ingredients, excipients, and chemicals were selected for the development of the polyherbal lotion intended for the management of Pediculosis capitis. All raw materials and excipients used were of pharmaceutical or cosmetic grade.

Herbal Ingredients

Coconut oil – acts as an occlusive agent and helps suffocate lice.

Neem oil – possesses strong pediculicidal, antimicrobial, and anti-inflammatory activity.

Karanja oil (Pongamia pinnata) – known for insecticidal properties.

Castor oil – enhances viscosity, conditioning effect, and contributes mild insecticidal action.

Tea tree oil – exhibits proven anti-lice, antiseptic, and antifungal activity.

Camphor – provides counter-irritant, soothing, and insect-repellent effects.

Aloe vera gel – acts as a skin-soothing, moisturizing, and healing agent.

Onion extract – possesses sulfur-containing compounds with potential pediculicidal action.

Lemon extract – provides mild acidity, cleansing effect, and helps in nit-loosening.

Base Ingredients and Excipients

Glycerol (Humectant) – improves moisture retention and prevents dryness.

Glyceryl monostearate (GMS) – used as an emulsifier and thickening agent.

Cetostearyl alcohol – stabilizes the emulsion and provides consistency.

Stearic acid – acts as a co-emulsifier and thickener to improve lotion texture.

Purified water – used as the aqueous phase for the formulation.

Equipment and Apparatus

Hot plate with magnetic stirrer

Homogenizer

Water bath

pH meter

Digital weighing balance

Glassware (beakers, cylinders, funnels, spatulas)

METHOD OF PREPARATION

Formulation Design

Preparation of  four formulations (F1–F4).

Varying concentrations of active herbal ingredients.

Mild → Moderate → Strong → Highly potent formulations.

Method of Preparation

Step 1: Preparation of Oil Phase

Coconut oil, neem oil, karanja oil, castor oil, glyceryl monostearate, cetostearyl alcohol, and stearic acid were accurately weighed and transferred into a clean beaker. The mixture was heated on a water bath at 70–75°C until all solid components melted completely and a clear, homogeneous oil phase was obtained. Tea tree oil and camphor were added to the oil phase and mixed gently to avoid evaporation of volatile components.

 

Figure 1: preparation of oil phase

 

Step 2: Preparation of Aqueous Phase

Purified water was taken in another beaker and heated to the same temperature (70–75°C). Glycerol was added and stirred until completely dissolved. Aloe vera gel, onion extract, and lemon extract were slowly incorporated with continuous stirring to obtain a uniform aqueous phase .

 

 

Figure 2: preparation of aqueous phase

Step 3: Emulsification

The hot oil phase was slowly added to the aqueous phase with continuous stirring using a mechanical stirrer. The emulsification process was carried out carefully to ensure uniform dispersion of oil  droplets, resulting in the formation of a smoot oilin-water emulsion.

 

 

  

Figure 3 : Both aqueous phase and oil phase        Figure 4 : Emulsification

 

 

Step 4: Cooling & Homogenization

After emulsification, the lotion was allowed to cool gradually to room temperature with continuous slow stirring. This step improves consistency, prevents phase separation, and enhances stability

Step 5: Final Adjustment & Storage

The final volume of the lotion was adjusted using purified water if required. The prepared formulations (F1–F4) were transferred into clean, dry, and properly labeled containers and stored at room temperature for further evaluation.

 

 

Figure 5:  Polyherbal anti-lice lotion

Prepared Formulations                 

F1 – Mild formulation (sensitive scalp)

F2 – Moderate strength (routine use)

F3 – Strong formulation (persistent lice)

F4 – Highly potent (severe / resistant lice)

Methods of Evaluation

Physicochemical Evaluation

Organoleptic evaluation (color, odor, appearance)

pH determination

Viscosity measurement

Spreadability test

Homogeneity check

RESULTS

ORGANOLEPTIC EVALUATION :

The organoleptic properties of F1-F4 was been evaluated and shown in table 1.

 

 

 

 

 

 

 

Formulation

Colour

Odour

Apperance

Texture

Homogeneity

F1

Pale yellow

Mild herbal

Clear and uniform

Smooth and light

Homogeneous

F2

Light yellow

Pleasant herbal

Uniform and glossy

Smooth

Homogeneous

F3

Light brown

Strong herbal

Uniform no seperation

Sticky thick

Homogeneous

F4

Brownish

Characteristic herbal

Uniform and stable

Thick and smooth

Homogeneous

 

pH DETERMINATION

pH values ranged from 6.4 to 7.0 which is compatible with scalp PH and suitable for topical application.

 

 

Table 2: PH values of formulations

Formulation

pH (±)mean SD

F1

6.4 ±0.05

F2

6.6 ±0.04

F3

6.8±0.03

F4

7.0±0.02

 

 

 

 

GRAPH 1: Showing pH variation among formulations ( F1-F4 )

 

Illustrates the pH values of polyherbal anti-lice lotion formulations (F1–F4). All formulations exhibited pH within the acceptable range for scalp application, indicating dermatological compatibility. A gradual increase in pH was observed with increasing herbal concentration.

VISCOSITY MEASUREMENT

Viscosity increased proportionality with herbal content, improving adhesion to hair shafts and scalp.

 

Table 3: viscosity of polyherbal anti-lice lotion

Formulation

Viscosity (Cp)

F1

3200±45

F2

3400±38

F3

3600±42

F4

3200±40

 

 

 

 

 

 

 

 

GRAPH 2: Viscosity profile of formulations(F1-F4)

 

It shows the viscosity variation among formulations F1–F4. An increase in viscosity was observed with higher herbal content, suggesting improved consistency and prolonged contact time on the scalp.

SPREADABILITY RESULTS

All the formulations showed good spreadability , ensuring ease of application and uniform coverage

 Table 4: spreadability results

Formulation

Spreadability (cm/sec )

F1

6.8±0.2

F2

7.2±0.3

F3

7.5±0.2

F4

7.9 ±0.3

 

Improved spreadibility in F4 indicates better user compliance without excessive runoff .

SKIN IRRITATION TEST

None of the formulations produced erythema , edema ,or irritation.

Table 5 : showing results of skin irritation test

Formulation

Observation

F1

No irritation

F2

No irritation

F3

No irritation

F4

No irritation

PEDICULICIDAL ACTIVITY

A concentration dependent increase in anti-lice efficacy was observed .

Table 6 :pediculicidal activity results

Formulation

Lice mortality (%)

F1

82±2

F2

88±1

F3

92±1

F4

96±1

 

 

 

 

GRAPH 3 : Comparative pediculicidal activity of formulation (F1-F4)

 

Exhibited the highest pediculicidal activity, possibly due to synergistic action of multiple herbal extracts affecting lice respiration and nervous system.

STORAGE CONDITIONS

The formulation was packed in a tightly closed, inert container and stored under the following conditions:

Table 7: Storage conditions

Storage condition

Temperature

Duration

Refrigerated condition

4 ±2 °C

3 months

Room temperature

25 ±2 °C

3 months

Accelerated condition

40 ±2 °C

3 months

 

STABLILITY STUDIES

The stability studies of the formulated poly herbal anti lice lotion were conducted according to ICH guideline principles  (Q1A –Stability testing of new drug products )with slight modifications suitable for cosmetic /herbal formulations .

RESULTS OF STABILITY STUDIES :

 

Table 8: Stability evaluation of polyherbal Anti-lice lotion

Parameter

Initial

30 days

60 days

90 days

Appearance

 

Smooth,

Homogeneous

No change

No change

No change

Colour

 

light herbal green

No change

No change

No change

Odour

Pleasant herbal

No change

No change

No change

Phase separation

Absent

Absent

Absent

Absent

Microbialgrowth

Not observed

Not observed

Not observed

Not observed

 

 

DISCUSSION

Pediculosis capitis remains a persistent public health concern, particularly among school-going children, due to its highly contagious nature and increasing resistance to conventional chemical pediculicides. The present study was undertaken with the objective of formulating and evaluating a polyherbal anti-lice lotion that could provide effective lice control while minimizing the adverse effects commonly associated with synthetic agents. The discussion focuses on formulation rationale, evaluation outcomes, and the overall effectiveness of the developed herbal preparation. The selection of herbal ingredients for the formulation was based on their documented insecticidal, ovicidal, and scalp-friendly properties. Herbs such as neem, tea tree, eucalyptus, and other plant-derived components are traditionally known to interfere with the nervous system of lice, disrupt respiration, and weaken egg attachment to hair shafts. The combination of multiple herbs in a single formulation was intended to produce a synergistic effect, thereby enhancing efficacy and reducing the likelihood of resistance development. Unlike single-component formulations, polyherbal systems offer multiple mechanisms of action, which is a significant advantage in the management of recurrent infestations.During formulation development, emphasis was placed on achieving an optimal balance between effectiveness, stability, and user acceptability. The lotion base was chosen to ensure uniform distribution of active constituents over the scalp and hair while maintaining adequate viscosity for easy application. The physical appearance of the formulation remained consistent throughout the study period, indicating good formulation stability. The absence of phase separation or precipitation suggests that the herbal extracts were compatible with the selected excipients.

CONCLUSION

The development of the polyherbal anti-lice lotion highlights the potential of medicinal plants as effective and safer alternatives to synthetic pediculicides in the management of pediculosis capitis. The selected herbal extracts, known for their insecticidal, ovicidal, antimicrobial, and soothing properties, work synergistically to eliminate lice and their eggs while reducing scalp irritation and inflammation. Unlike many chemical treatments, which may cause resistance, toxicity, or adverse skin reactions, the polyherbal formulation offers a comparatively gentle yet efficient approach.The prepared lotion demonstrated desirable physicochemical characteristics such as appropriate pH, homogeneity, spreadability, stability, and ease of application. These parameters indicate that the formulation is suitable for topical use and patient compliance. Additionally, the herbal ingredients contribute conditioning and scalp-nourishing benefits, improving overall hair health while treating infestation.From a safety perspective, the formulation minimizes the risk of harsh chemical exposure, making it more suitable for children and individuals with sensitive skin. The eco-friendly and biodegradable nature of herbal components also supports environmental sustainability.In conclusion, the polyherbal anti-lice lotion represents a promising, cost-effective, and patient-friendly alternative for the treatment of head lice. With further clinical evaluation and large-scale studies, this formulation can be developed into a commercially viable herbal product that aligns with the increasing global demand for natural and safe therapeutic solutions.

ABBREVIATIONS

API - Active Pharmaceutical Ingredient, ALM-Anti-Lice Medication, pH-Potential of Hydrogen, SD-Standard Deviation,WHO-World Health Organization, w/w-Weight by Weight, %-Percentage,  ml-Millilitre, mg-Milligram,°C-Degree Celsius, PLI-Pediculosis Capitis (Head Lice Infestation).

REFERENCES

  1. Falagas ME, Matthaiou DK, Rafailidis PI, Panos G, Pappas G. Worldwide prevalence of head lice. Emerg Infect Dis. 2008;14(9):1493-4.
  2. Heukelbach J, Feldmeier H. Ectoparasites—the underestimated realm. Lancet. 2004;363(9418):889-91.
  3. Burgess IF. Human lice and their management. Adv Parasitol. 2014;83:271-342.
  4. Feldmeier H. Pediculosis capitis: new insights into epidemiology, diagnosis and treatment. Curr Opin Infect Dis. 2012;25(2):133-8.
  5. Abdel-Ghaffar F, Semmler M, Al-Rasheid KA, Mehlhorn H. Efficacy of neem seed extract shampoo on head lice. Parasitol Res. 2012;110(1):329-34.
  6. Greive KA, Barnes TM. Comparison of tea tree oil gel and permethrin lotion in treating head lice. Aust J Dermatol. 2018;59(2):e99-e105.
  7. Dubey NK, Kumar R, Tripathi P. Global promotion of herbal medicines. Curr Sci. 2004;86(1):37-41.
  8. Abdel-Ghaffar F, Semmler M, Al-Quraishy S, Al-Rasheid KA. Efficacy of neem seed extract shampoo on head lice and their eggs. Parasitol Res. 2012;110(1):329-35.
  9. Mukherjee PK, Nema NK, Venkatesh P, Debnath PK. Changing the paradigm for botanical drug development: polyherbal formulations. Phytother Res. 2012;26(4): 16-22.
  10. Burgess IF. Human lice and their management. Adv Parasitol. 2014;74:271-342.
  11. Tadros T, Izquierdo R, Esquena J, Solans C. Formation and stability of nano-emulsions. Adv Colloid Interface Sci. 2004;108-109:303–18.
  12. Shakeel F, Ramadan W, Gargum H, Farouk A. Effect of penetration enhancers on transdermal delivery of herbal formulations. J Drug Deliv Sci Technol. 2015;29:23–30.
  13. Heukelbach J, Canyon DV, Speare R. The effect of natural products on head lice: a clinical and laboratory evaluation. J Pediatr Infect Dis. 2008;3(1):19–23.
  14. Tabashnik, B.E. Managing resistance with multiple pesticide tactics: Theory, evidence, and recommendations. J. Econ. Entomol. 1989, 82, 1263–1269. 
  15. Sreedhar V, Mastanaiah J, Chakrapani B, Narayana DV, Babu BN, et al. Pharmacological Screening of Anti Lice and Antidandruff Activity of Ethanolic Extract of Leaves of Datura metel. Pharmacogn J. 2020;12(6):1653-7.
  16. Gupta AK, Chitme HR. Herbal Medicines for Health. Eastern Pharmacist. 2000;440(41):28.
  17. .Hand SS. Herbal raw material and traditional remedies. Eastern Pharmasis. 2000;447(38):23.
  18. Sawant PS, Sankpal PB, Jagtap AM, Gavade AS, Vambhurkar GB. Formulation and evaluation of herbal shampoo. Res J Top Cosmet Sci 2020; 11(1): 1-4.
  19. El-Sharawy RT, Elkhateeb A, Marzouk MM, Abd El-Latif RR, Abdelrazig SE, El-Ansari MA. Antiviral and antiparasitic activities of clovamide: The major constituent of Dichrostachys cinerea (L.) wight et arn J Appl Pharm Sci 2017; 7(9): 219-23.
  20. Gutiérrez MM, Werdin-González JO, Stefanazzi N, Bras C, Ferrero  AA. The potential application of plant essential oils to control Pediculus humanus capitis (Anoplura: Pediculidae). Parasitol Res 2016; 115(2): 633-41..

Reference

  1. Falagas ME, Matthaiou DK, Rafailidis PI, Panos G, Pappas G. Worldwide prevalence of head lice. Emerg Infect Dis. 2008;14(9):1493-4.
  2. Heukelbach J, Feldmeier H. Ectoparasites—the underestimated realm. Lancet. 2004;363(9418):889-91.
  3. Burgess IF. Human lice and their management. Adv Parasitol. 2014;83:271-342.
  4. Feldmeier H. Pediculosis capitis: new insights into epidemiology, diagnosis and treatment. Curr Opin Infect Dis. 2012;25(2):133-8.
  5. Abdel-Ghaffar F, Semmler M, Al-Rasheid KA, Mehlhorn H. Efficacy of neem seed extract shampoo on head lice. Parasitol Res. 2012;110(1):329-34.
  6. Greive KA, Barnes TM. Comparison of tea tree oil gel and permethrin lotion in treating head lice. Aust J Dermatol. 2018;59(2):e99-e105.
  7. Dubey NK, Kumar R, Tripathi P. Global promotion of herbal medicines. Curr Sci. 2004;86(1):37-41.
  8. Abdel-Ghaffar F, Semmler M, Al-Quraishy S, Al-Rasheid KA. Efficacy of neem seed extract shampoo on head lice and their eggs. Parasitol Res. 2012;110(1):329-35.
  9. Mukherjee PK, Nema NK, Venkatesh P, Debnath PK. Changing the paradigm for botanical drug development: polyherbal formulations. Phytother Res. 2012;26(4): 16-22.
  10. Burgess IF. Human lice and their management. Adv Parasitol. 2014;74:271-342.
  11. Tadros T, Izquierdo R, Esquena J, Solans C. Formation and stability of nano-emulsions. Adv Colloid Interface Sci. 2004;108-109:303–18.
  12. Shakeel F, Ramadan W, Gargum H, Farouk A. Effect of penetration enhancers on transdermal delivery of herbal formulations. J Drug Deliv Sci Technol. 2015;29:23–30.
  13. Heukelbach J, Canyon DV, Speare R. The effect of natural products on head lice: a clinical and laboratory evaluation. J Pediatr Infect Dis. 2008;3(1):19–23.
  14. Tabashnik, B.E. Managing resistance with multiple pesticide tactics: Theory, evidence, and recommendations. J. Econ. Entomol. 1989, 82, 1263–1269. 
  15. Sreedhar V, Mastanaiah J, Chakrapani B, Narayana DV, Babu BN, et al. Pharmacological Screening of Anti Lice and Antidandruff Activity of Ethanolic Extract of Leaves of Datura metel. Pharmacogn J. 2020;12(6):1653-7.
  16. Gupta AK, Chitme HR. Herbal Medicines for Health. Eastern Pharmacist. 2000;440(41):28.
  17. .Hand SS. Herbal raw material and traditional remedies. Eastern Pharmasis. 2000;447(38):23.
  18. Sawant PS, Sankpal PB, Jagtap AM, Gavade AS, Vambhurkar GB. Formulation and evaluation of herbal shampoo. Res J Top Cosmet Sci 2020; 11(1): 1-4.
  19. El-Sharawy RT, Elkhateeb A, Marzouk MM, Abd El-Latif RR, Abdelrazig SE, El-Ansari MA. Antiviral and antiparasitic activities of clovamide: The major constituent of Dichrostachys cinerea (L.) wight et arn J Appl Pharm Sci 2017; 7(9): 219-23.
  20. Gutiérrez MM, Werdin-González JO, Stefanazzi N, Bras C, Ferrero  AA. The potential application of plant essential oils to control Pediculus humanus capitis (Anoplura: Pediculidae). Parasitol Res 2016; 115(2): 633-41..

Photo
Dr. Jarupala Gangadhar Naik
Corresponding author

Sri Venkateswara College of Pharmacy, Chittoo, Andhra Pradesh, India

Photo
R. B. Yasaswini
Co-author

Sri Venkateswara College of Pharmacy, Chittoo, Andhra Pradesh, India

Photo
Dulla Venkata Kishan Reddy
Co-author

Sri Venkateswara College of Pharmacy, Chittoo, Andhra Pradesh, India

Photo
S. Lokesh
Co-author

Sri Venkateswara College of Pharmacy, Chittoo, Andhra Pradesh, India

Photo
Kuruva Lakshmikanth
Co-author

Sri Venkateswara College of Pharmacy, Chittoo, Andhra Pradesh, India

Photo
Govinda Kumar Yadav
Co-author

Sri Venkateswara College of Pharmacy, Chittoo, Andhra Pradesh, India

Photo
Dr. D. Ravi kiran
Co-author

Sri Venkateswara College of Pharmacy, Chittoo, Andhra Pradesh, India

R.B. Yasaswini, Dulla Venkata Kishan Reddy, S. Lokesh, Kuruva Lakshmikanth,Govinda Kumar Yadav, Dr. D. Ravi kiran, Dr.Jarupala Gangadhar Naik, Formulation And Evaluation of Polyherbal Lotion for The Management of Pediculosis Capitis, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 2, 2246-2254. https://doi.org/10.5281/zenodo.18639344

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