Polyherbal Gel Formulations for the Management of Mouth Ulcers: A Critical Review

Arun Shinde, Yashanjali Sabale, Anil Pawar, Ambadas Katarnavare, Pratik Sabale, Chaitanya Maharnavar,

doi:10.5281/zenodo.18791109

Review Paper | Open Access
Volume 04 | Issue 02 | Article Id IJPS/260402382

Polyherbal Gel Formulations for the Management of Mouth Ulcers: A Critical Review
Arun Shinde* Yashanjali Sabale Anil Pawar Ambadas Katarnavare Pratik Sabale Chaitanya Maharnavar
Mula Education Society's College of Pharmacy, Sonai, Newasa, Ahilyanagar 414105

Abstract

Polyherbal gels have emerged as a promising therapeutic approach for the management of mouth ulcers due to their multifactorial pharmacological actions, improved patient compliance, and reduced adverse effects compared to conventional therapies. Mouth ulcers are characterized by complex pathological processes involving inflammation, oxidative stress, microbial imbalance, and delayed epithelial regeneration. Polyherbal gel formulations integrate multiple medicinal plant extracts within a suitable mucoadhesive base, enabling synergistic modulation of inflammatory mediators, enhancement of antioxidant defences, antimicrobial activity, and promotion of wound healing. Recent advances in network pharmacology and systems biology provide mechanistic insights into the multi-component, multi-target interactions of herbal constituents, validating the scientific rationale for polyherbal therapy. This review critically analyses the pathophysiology of mouth ulcers, selection of herbal components, formulation strategies, evaluation parameters, mechanistic evidence, and translational challenges associated with polyherbal mouth ulcer gels, highlighting current research gaps and future directions.

Keywords

Polyherbal gel; Mouth ulcers; Mucoadhesive drug delivery; Network pharmacology; Systems biology; Oral wound healing; Herbal formulations

Introduction

Oral ulcerative disorders, particularly recurrent aphthous stomatitis (RAS), affect approximately 5–25% of the global population and are characterized by painful, shallow ulcers of the non-keratinized oral mucosa [1–5]. At the molecular level, RAS is associated with dysregulated cell-mediated immunity, elevated tumor necrosis factor-α (TNF-α), interleukins (IL-2, IL-6), and enhanced oxidative stress leading to epithelial apoptosis [3,4,42–44]. Current pharmacotherapy, including topical corticosteroids and antiseptics, primarily provides symptomatic relief and is often limited by recurrence and adverse effects such as mucosal atrophy and candidiasis [45–48].

Polyherbal gel formulations represent a rational therapeutic strategy by integrating multiple phytoconstituents capable of modulating inflammatory, oxidative, microbial, and wound- healing pathways simultaneously [6,32–35]. Furthermore, gel-based mucoadhesive delivery systems enhance residence time at the ulcer site, improving local bioavailability while minimizing systemic exposure [24–31].

2. Pathophysiology of Mouth Ulcers

Mouth ulcers arise from complex interactions among immune dysregulation, oxidative stress, microbial dysbiosis, and epithelial barrier disruption. Key inflammatory mediators, including TNF-α, IL-1β, IL-6, and IFN-γ, contribute to tissue damage and delayed healing [3,4,42]. Oxidative stress, measured by elevated malondialdehyde (MDA) and reduced superoxide dismutase (SOD) activity, exacerbates cellular apoptosis [7,8]. Microbial imbalance, including overgrowth of Streptococcus, Candida, and Actinomyces species, impedes normal mucosal repair [9–11].

3. Scientific Rationale for Polyherbal Therapy

Polyherbal therapy is grounded in the principles of systems biology and network pharmacology, wherein complex diseases are treated through multi-component, multi-target interventions rather than single-molecule approaches [33–36]. Mouth ulcers involve interconnected inflammatory, oxidative, immune, and microbial pathways; therefore, mono- target drugs often fail to provide sustained remission [1–5,44].

Polyherbal gels combine phytochemicals such as flavonoids, terpenoids, tannins, alkaloids, and polysaccharides, which collectively modulate NF-κB signalling, cytokine expression (TNF-α, IL-1β, IL-6), redox balance, angiogenesis, and epithelial regeneration [8,33–35,42]. Synergistic interactions among these constituents reduce required doses and minimize adverse effects compared to isolated compounds [57].

4. Phytochemical and Pharmacological Basis of Key Herbs and Network Pharmacology Insights

Recent advances in network pharmacology have enabled mapping of herb–compound–target– pathway relationships, providing mechanistic validation for polyherbal formulations [34,35]. Databases such as TCMSP, STRING, and KEGG pathway analysis have demonstrated that key phytoconstituents from Aloe vera, Curcuma longa, Glycyrrhiza glabra, and Azadirachta indica interact with molecular targets involved in inflammation, apoptosis, oxidative stress, and tissue remodelling [8–10,34–36].

For example, curcumin targets NF-κB, COX-2, and STAT3 pathways, while glycyrrhizin modulates HMGB1 and glucocorticoid receptor signaling, collectively attenuating inflammatory cascades [8,10]. Aloe-derived polysaccharides activate fibroblast growth factors and VEGF-mediated angiogenesis, accelerating wound repair [7]. Network analysis reveals convergence of these targets on pathways such as TNF signaling, MAPK signaling, and HIF-1 signaling, supporting the rationale for synergistic herbal combinations rather than monotherapy [34–36].

5. Formulation Strategies

Polyherbal gels are typically prepared using mucoadhesive polymers such as Carbopol, HPMC, sodium CMC, or natural gums to ensure localized drug retention and sustained release [24– 31]. Factors such as polymer concentration, pH, viscosity, and phytochemical compatibility are critical for gel stability, rheology, and bioadhesive performance [18–21]. Formulation optimization often relies on experimental design approaches, including Quality-by-Design (QbD), factorial design, and response surface methodology [18–21].

6. Evaluation Parameters and Systems Biology-Oriented Assessment

Beyond routine physicochemical evaluation, modern assessment of polyherbal mouth ulcer gels increasingly incorporates systems-level endpoints [24–31]. These include quantification of inflammatory biomarkers (TNF-α, IL-6), oxidative stress markers (MDA, SOD), gene expression profiling, and microbiome compatibility studies [42–44]. Integration of in-vitro, ex- vivo buccal permeation, and in-vivo efficacy data enables improved in-vitro–in-vivo correlation (IVIVC) and formulation optimization under Quality-by-Design frameworks [18–21,52,53].

6.1 Physicochemical Evaluation

Physicochemical assessment ensures gel stability, uniformity, and suitability for oral application. Key parameters include:

- - Organoleptic properties: Color, odor, and texture evaluation ensure patient acceptability and consistency between batches [17, 24, 25].
  - pH measurement: Oral gels must maintain a physiological pH (6–7.4) to prevent mucosal irritation and maintain active constituent stability [24, 30].
  - Viscosity and rheology: Measured using a Brookfield viscometer, viscosity affects spreadability, drug release, and mucoadhesion [18, 19, 24]. Thixotropic behavior is desirable for easy application [18].
  - Spreadability: Determines the gel’s ability to cover the ulcer surface uniformly; usually assessed by placing a gel between glass slides and measuring the spread under a defined weight [18, 21].
  - Homogeneity and phase separation: Visual inspection and microscopy to ensure no precipitation or phase separation occurs during storage [17, 21].
  - Stability studies: Short-term (30–90 days) and long-term (6–12 months) stability under varied temperature and humidity, per ICH guidelines, to confirm retention of physicochemical properties and bioactivity [43, 44].

6.2 Mechanical and Adhesive Properties

Mucoadhesion is crucial for prolonged residence time on oral mucosa, enhancing local bioavailability:

- - Mucoadhesive strength: Measured using a texture analyzer or modified balance method; indicates the force required to detach the gel from a mucosal substrate [30, 31].
  - Extrudability: Ease of gel expulsion from tubes is tested using uniform pressure, relevant for patient compliance [18, 24].
  - Consistency and firmness: Evaluated using penetrometer or texture profile analysis, which impacts gel retention and ease of application [19, 24].
- Drug Content and Uniformity
  - Total phytochemical content: Quantification of active constituents like flavonoids, phenolics, glycyrrhizin, curcumin using UV–Vis spectrophotometry or HPLC ensures batch-to-batch uniformity [8, 10, 17].
  - Content uniformity: Ensures consistent dosing per gel application; crucial for polyherbal formulations with multiple active ingredients [18, 21].
- In-Vitro Release and Permeation Studies
  - Drug release kinetics: Assessed using dialysis membrane or Franz diffusion cells in simulated saliva or phosphate buffer (pH 6.8). Data fitted to kinetic models (Zero-order, First-order, Higuchi, Korsmeyer-Peppas) to predict release behavior [35, 36].
  - Ex-vivo permeation: Porcine or bovine buccal mucosa used to estimate drug penetration and retention at ulcer site [29, 32–34].
  - Swelling index: Degree of gel hydration affects mucoadhesion and release profile; measured by weight gain in simulated saliva [18, 30].

6.5 Antimicrobial and Antioxidant Activity

- - Antimicrobial evaluation: In-vitro agar well diffusion or broth microdilution tests against Streptococcus mutans, Candida albicans, Actinomyces species to determine the gel’s ability to prevent secondary infections [6, 9, 32].
  - Antioxidant potential: DPPH, ABTS, or FRAP assays to assess free radical scavenging properties, relevant to reducing oxidative stress in ulcerative lesions [7, 8, 42].

6.6 In-Vivo Efficacy

Animal models (rats, hamsters) and clinical trials are employed to evaluate:

- - Ulcer healing rate: Measured by reduction in ulcer area over time [31, 32, 42].
  - Histopathological assessment: Collagen deposition, re-epithelialization, angiogenesis, and inflammatory cell infiltration [7, 42, 43].
  - Biomarker analysis: TNF-α, IL-1β, IL-6, MDA, SOD levels measured in tissue or saliva to evaluate mechanistic efficacy [42–44].

6.7 Safety and Irritation Studies

- - Oral mucosal irritation: Tested in animal models or human volunteers to ensure non- toxicity and lack of sensitization [18, 19].
  - Cytotoxicity assays: MTT or trypan blue exclusion assay on buccal keratinocytes to confirm cellular safety [7, 42].

6.8 Systems Biology and Network Pharmacology-Based Evaluation

Recent studies integrate omics-based analysis to predict molecular mechanisms:

- - Gene expression profiling: Assessing modulation of inflammatory, apoptotic, and angiogenic genes [34–36].
  - Pathway analysis: Network pharmacology predicts targets of phytoconstituents (NF- κB, MAPK, VEGF, Nrf2) to validate multi-target action [33–36].
  - Multi-omics integration: Combines metabolomics, proteomics, and transcriptomics to understand polyherbal synergistic effects on oral ulcer healing [34, 35, 36].

7. Preclinical and Clinical Evidence

Preclinical studies using chemically and mechanically induced oral ulcer models have demonstrated that polyherbal gels significantly reduce ulcer area, inflammatory cell infiltration, and healing time compared to placebo and single-herb formulations [31,32,42]. Downregulation of TNF-α, IL-1β, and lipid peroxidation markers, along with increased collagen deposition and angiogenesis, has been reported in animal models treated with Aloe vera-, Curcuma longa-, and Glycyrrhiza glabra-based combinations [7–10,42,43].

Clinical evidence suggests that herbal and polyherbal gels provide statistically significant pain reduction and accelerated epithelialization compared to conventional treatments [1,2,45,46]. However, heterogeneity in herbal composition, polymer systems, dosing frequency, and clinical endpoints limits cross-study comparison and meta-analysis [44,48].

8. Critical Comparison of Polyherbal Mouth Ulcer Gel Studies

Author (Year)	Herbal Components	Polymer System	Study Model	Key Outcomes	Mechanistic Insights	Limitations
Kumar et al. (2016) [31]	Aloe vera + Glycyrrhiza glabra	Carbopol 934	Rat oral ulcer model	Faster epithelialization, ↓ inflammation	Down regulation of TNF-α, IL-6; enhanced collagen deposition	Lack of biomarker analysis; short duration
Deshmukh et al. (2014) [32]	Neem + Turmeric + Tulsi	HPMC	In vitro + animal	Broad antimicrobial activity	Inhibition of Candida albicans and Streptococcus mutans; antioxidant activity	No clinical correlation; herbal standardization not reported
Sharma et al. (2010) [42]	Polyphenol -rich extracts	Sodium CMC	Animal model	↓ Oxidativ stress markers; improved healing	Reduced MDA levels; ↑ SOD and catalase activity	Short study duration; single animal model
Akintoye et al. (2014) [46]	Herbal gel (unspecified mix)	Carbopol	Clinical study	Pain score reduction; faster healing	Not reported; assumed anti-inflammatory effects	Poor herbal standardization; mechanism not validated
Arduino et al. (2008) [45]	Aloe-based gel	Mucoadhesive gel	Clinical trial	Reduced ulcer duration; pain relief	Modulation of fibroblast growth factors; angiogenesis	Monotherapy only; small sample size
Jadhav et al. (2024) [22]	Aloe vera + Psidium guajava + Turmeric	HPMC + Carbopol blend	Rat + rabbit oral ulcer model	↓ Ulcer area; improved histology	Down regulation of NF-κB; ↑ VEGF- mediated angiogenesis	Limited clinical translation; no PK data
Patel et al. (2024) [21]	Curcuma longa + Glycyrrhiza glabra + Azadirachta indica	Carbopol 940	Ex vivo + clinical pilot	Sustained release; improved patient compliance	Multi-target modulation: TNF-α, IL- 1β, ROS scavenging	Pilot study; small sample size; short follow-up
Kale & Deshmukh (2024) [17]	Polyherbal extract mix	Sodium CMC	In vitro + clinical	Significant pain reduction; antimicrobial effect	Inhibition of microbial biofilm; antioxidant effect	Lack of detailed mechanistic biomarkers; heterogeneous herbal composition
Thummar et al. (2025) [18]	Aloe vera + Ocimum sanctum + Curcuma longa	HPMC	Rat ulcer model	Faster epithelialization; ↓ Inflammatory cells	↑ Collagen deposition; ↓ MDA levels	Single animal model; short duration
Hasan et al. (2021) [15]	Various polyherbal gels	Multiple polymers	Randomized clinical trials	Pain reduction; faster healing; improved patient satisfaction	Suggested anti-inflammatory and anti-oxidant effects	High heterogeneity; variable herbal quality

9. Research Gaps and Future Directions

Significant gaps remain in standardized extract preparation, long-term safety evaluation, mechanistic biomarker validation, and well-powered randomized clinical trials. Integration of omics-based validation, network pharmacology modeling, and quality-by-design formulation strategies can bridge preclinical findings to clinical translation [18,19,34–36,38–41].

10. CONCLUSION AND FUTURE PERSPECTIVES

Polyherbal gels represent a scientifically promising and clinically relevant strategy for the management of oral ulcerative conditions by integrating multitarget pharmacological actions with localized drug delivery. The reviewed evidence highlights that phytoconstituents such as flavonoids, terpenoids, alkaloids, tannins, and phenolic acids collectively modulate inflammatory mediators (NF-κB, COX-2, TNF-α), oxidative stress pathways (Nrf2, ROS scavenging), microbial virulence factors, and tissue regeneration mechanisms. Compared with synthetic corticosteroids and antiseptics, polyherbal gels offer superior safety profiles, reduced recurrence rates, and enhanced patient compliance.

Network pharmacology and systems biology analyses further reveal that polyherbal formulations act on interconnected molecular networks rather than isolated targets, supporting their suitability for multifactorial disorders such as recurrent aphthous stomatitis. However, significant gaps remain, including lack of standardized extracts, limited mechanistic validation, inadequate pharmacokinetic–pharmacodynamic correlations, and scarcity of well-designed randomized clinical trials.

Future research should focus on

integrating omics-based validation of network predictions,
quality-by-design–driven formulation optimization,
advanced mucoadhesive and stimuli-responsive gel systems,
harmonized regulatory frameworks for herbal oral care products.

Such advances will facilitate translational acceptance of polyherbal mouth ulcer gels as evidence-based therapeutics in modern dentistry and oral medicine.

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