Safety, Efficacy, and Physicochemical Characterization of Tinospora crispa Ointment: A Community-Based Formulation against Pediculus humanus capitis

Abstract

The high prevalence of pediculosis capitis, commonly known as head lice (Pediculus humanus capitis) infestation, has led to the preparation of a community-based pediculicidal ointment, which is made of common household items and the extract of Tinospora crispa stem. The present study aimed to evaluate the safety, efficacy, and physicochemical characteristics of the T. crispa pediculicidal ointment. The physicochemical properties of the ointment were characterized, and safety was determined using acute dermal irritation test (OECD 404), while the efficacy was assessed using an in vitro pediculicidal assay. Furthermore, the chemical compounds present in T. crispa were identified using liquid-liquid extraction followed by ultra-performance liquid chromatography quadruple time-of-flight mass spectrometric (UPLC-qTOF/MS) analysis. The community-based ointment formulation was light yellow in color, homogeneous, smooth, with distinct aromatic odor and pH of 6.92±0.09. It has spreadability value of 15.04±0.98 g·cm/sec and has thixotropic behavior. It was also found to be non-irritant, with a primary irritation index value of 0.15. Moreover, it was comparable to the pediculicidal activity of the positive control Kwell®, a commercially available 1% permethrin shampoo (P>0.05), and was significantly different to the activity of the negative control ointment, a mixture of palm oil and candle wax (P<0.05). These findings suggested that the community-based T. crispa pediculicidal ointment is safe and effective, having acceptable physicochemical characteristics. Its activity can be attributed to the presence of compounds moupinamide and physalin I.

Keywords: Pediculus humanus capitis; Tinospora crispa; dermal irritation; ointment; pediculicidal assay.

Fig. 1

Microscopic picture of an adult Pediculus humanus capitis (head louse).

Fig. 2

Rheogram of Tinospora crispa ointment at 25°C.

Fig. 3

Percent activity of T. crispa ointment, positive control (1% permethrin, Kwell^® shampoo) and negative control ointment (palm oil+pulverized candle) on head lice. (A) Percentage of head lice that are active, post-treatment. (B) Percentage of head lice considered having ‘some vital signs’, post-treatment. (C) Percentage mortality of head lice considered having ‘no vital signs’, post-treatment. Different lower case letters in mean significantly different, P<0.05, whereas similar letters mean not significantly different from each other.

Fig. 4

Base peak ion chromatogram of T. crispa extract, showing 3 unique peaks as compared to palm oil (blank). (A) Moupinamide. (B) Physalin I. (C) An unknown compound.