INTRODUCTION:

BACTERIAL INFECTION:

Bacterial illnesses have a significant impact on public health. Disease can arise from the
bacteria themselves or from the body's response to them, and it can occur in any part of the
body. Humans can acquire bacteria through food, water, air, or living vectors. The primary
modes of transmission for bacterial infections include contact, airborne particles, droplets,
vectors, and vehicles. Preventive measures can greatly reduce morbidity and mortality.
Examples of these efforts include water treatment, vaccinations for humans and animals,
personal hygiene practices, and safer sexual behaviours. The growing issue of antibiotic
resistance in bacteria necessitates careful use of these medications.

Bacterial infections can target any area of the body. Each bacterial species tends to prefer
certain organs while avoiding others. For example, Neisseria meningitides is known to cause
meningitis by infecting the meninges, the protective covering of the central nervous system,
and it can also lead to pneumonia by affecting the lungs. However, it does not typically
cause skin infections. On the other hand, Staphylococcus aureus, which is commonly found
on people's skin or mucous membranes, often leads to skin and soft tissue infections but can
also easily enter the bloodstream and infect the lungs, abdomen, heart valves, and nearly
every other part of the body.

STAPHYLOCOCCUS AUREUS:

Bacteraemia caused by Staphylococcus aureus is perhaps best known as a key indicator of an

S. aureus infection. Numerous studies have reported on the prevalence, prognosis, and
outcomes of S. aureus bacteraemia (SAB) in industrialized regions. However, significant
uncertainties remain about the epidemiology of SAB, particularly in less developed areas.
Furthermore, there is still a lack of high-quality evidence to guide the management of SAB.

EPIDEMIOLOGY:

The prevalence of SAB ranges from 10 to 30 cases per 100,000 person-years in

industrialized countries. Danish longitudinal studies provide significant insights into how
changes in healthcare access impact the incidence of SAB. Between 1957 and 1990, the
incidence of SAB increased from 3 to 20 cases per 100,000 person-years. During this period,
there was also a rapid rise in the rates of invasive medical procedures and hospitalizations in
Denmark. Consequently, nosocomial acquisition emerged as a key factor contributing to the
overall increase in SAB prevalence. Since 1990, however, Denmark's SAB incidence has
remained relatively stable at around 21.8 cases per 100,000 person-years.

In the last two decades, methicillin-resistant S. aureus (MRSA) has influenced overall SAB
rates in varying ways, which may have led to a stabilization of these rates. For example,
while the rates of methicillin-susceptible S. aureus (MSSA) bacteraemia held steady from
1991 to 2005, the incidence of MRSA bacteraemia in Quebec, Canada, surged from 0 to 7.4
cases per 100,000 person-years. Similar trends of increasing MRSA bacteraemia incidence
were noted in Oxfordshire, UK, from 1997 to 2003, Minnesota from 1998 to 2005, and
Calgary, Canada, from 2000 to 2006.

The rise in MRSA bacteraemia in North America has largely been attributed to epidemic
community-associated clones like USA300, while in the UK, it has been linked to epidemic
healthcare-associated clones such as EMRSA-15 and EMRSA-16. Since 2005, MRSA
bacteraemia rates have significantly declined in most of these regions, likely due to
improvements in infection control measures. This decline was particularly evident in the UK,
where MRSA bacteraemia rates were halved between 2004 and 2011; similar reductions
have also been observed in the US, Australia, and France.

RISK GROUPS:

The highest rates of infection are found at both ends of the age spectrum, making age a key
factor in the occurrence of SAB. Research consistently indicates that infection rates are
elevated during the first year of life, dip during young adulthood, and then gradually rise as
individuals get older. For example, the incidence of SAB is just 4.7 per 100,000 person-years
among younger, healthier U.S. military personnel, while it exceeds 100 per 100,000 person-
years in those over 70.

Additionally, with male-to-female ratios around 1.5, being male is consistently associated
with a higher incidence of SAB. The reasons behind this increased risk remain unclear.
Ethnicity also plays a role in SAB occurrence. In the U.S., Black individuals experience a
higher incidence of invasive MRSA at 66.5 per 100,000 person-years compared to white
individuals at 27.7 per 100,000 person-years. Indigenous Australians have a 5.8 to 20 times
higher incidence of SAB than their nonindigenous counterparts. Similarly, in New Zealand,
the rates of SAB are significantly higher among Maori and Pacific Islanders compared to
Europeans. The differences between indigenous and nonindigenous populations cannot be
fully explained by socioeconomic factors alone. The impact of host genetic vulnerability on
these ethnic disparities has yet to be explored.

The occurrence of SAB is significantly more prevalent in individuals infected with HIV.
Studies indicate that the rates of SAB among HIV-positive individuals are 24 times higher
than those in the non-HIV-positive population, with two studies reporting rates of 494 per
100,000 person-years and 1,960 per 100,000 person-years, respectively. Even among HIV-
infected individuals who do not use injection drugs, the rates of SAB remain higher
compared to the non-HIV-infected population, although a significant portion of this increase
can be attributed to the high rates of injection drug use within the HIV-infected group.

Furthermore, SAB has been independently associated with low CD4 counts in those infected
with HIV. Notably, men who have sex with men (MSM) are more likely to experience
nosocomial SAB and have lower CD4 counts than injection drug users (IDUs).
Consequently, while injection drug use is a major factor contributing to community-onset
SAB in HIV-infected IDUs, nosocomial SAB is more frequently observed in MSM.

A Dutch study that monitored 758 IDUs over 1,640 person-years identified 10 confirmed
episodes of S. aureus IE, highlighting the elevated risk of SAB within the IDU community.
These findings suggest that there are at least 610 cases of SAB for every 100,000 person-
years. Additional factors that elevate the incidence of SAB among those who inject
substances include a higher prevalence of S. aureus colonization compared to the general
population, a greater frequency of skin and soft tissue infections (SSTIs), and an
environment conducive to the transmission of S. aureus among users.

Patients undergoing haemodialysis are significantly more prone to developing SAB. In

studies from Taiwan, Ireland, and the United States, the rates of SAB in patients reliant on
haemodialysis were reported as 3,064 per 100,000 person-years, 17,900 per 100,000 person-
years, and between 4,045 and 5,015 per 100,000 person-years, respectively. Key risk factors
for these patients include the use of cuffed, tunnelled catheters (like permacaths) for dialysis
and the presence of intravascular access devices.
Additionally, other host factors that can weaken the immune response, such as neutrophil
dysfunction, excess iron, diabetes, and higher colonization rates, may also increase the risk
of invasive S. aureus infections. Furthermore, the common practice of infrequent
vancomycin dosing in high-flux, large-pore-size artificial kidneys may not achieve adequate
trough levels, which can elevate the risk of relapsing SAB.

Staphylococcus bacteria are responsible for staph infections. Many healthy individuals carry
these germs on their skin or in their noses without any issues. Usually, these bacteria lead to
minor skin infections or no symptoms at all.

However, if the bacteria spread deeper into the body and enter the bloodstream, joints, bones,
lungs, or heart, staph infections can become life-threatening. An increasing number of
otherwise healthy people are experiencing potentially deadly staph infections.

Treatment typically involves antibiotics and cleaning the affected area. However, some staph
infections develop resistance to standard antibiotics or cease to respond to them. In such
cases, healthcare professionals may need to use antibiotics that have more severe side effects
to effectively treat resistant staph infections.

SIGNS AND SYMPTOMS:

Staph infections can lead to a range of problems, from minor skin conditions to severe health
issues. For example, staph bacteria can result in endocarditis, a serious infection affecting the
endocardium, which is the inner lining of the heart. The signs and symptoms of a staph
infection can differ significantly based on where the infection occurs and how severe it is.

When staph bacteria enter the bloodstream, they lead to a condition known as bacteraemia.
This condition is marked by symptoms such as fever and low blood pressure. Inside the
body, the bacteria can spread and lead to various diseases affecting:

- Internal organs like the heart (endocarditis), lungs (pneumonia), or brain (meningitis)
- Muscles and bones
- Surgically implanted devices, such as cardiac pacemakers or artificial joints
Toxic shock syndrome can also arise from certain strains of staph bacteria that produce
toxins, which can be life-threatening. This illness has been linked to surgery, skin wounds,
and certain types of tampons. It typically manifests suddenly with:

 A high fever
 Nausea and vomiting
 A rash on your palms and soles that looks like a sunburn
 Confusion
 Muscle aches
 Diarrhea
 Stomach pain

Septic arthritis

Septic arthritis is often caused by a staph infection. The bacteria often target the knees,
shoulders, hips, and fingers or toes. Artificial joints may also be at risk of infection. Signs
and symptoms may include:
 Joint swelling
 Severe pain in the affected joint
 Fever
FLUCLOXACILLIN:

Penicillin’s are a type of broad-spectrum antibiotic used to treat various infections, primarily
targeting Gram-positive bacteria. They are categorized into several subclasses based on their
antibacterial characteristics and chemical structure. One such subclass is Flucloxacillin
sodium (FLU), an active penicillin that is effective against bacteria that produce penicillinase
due to a modification in its molecular chain. FLU is commonly prescribed for serious
infections affecting the respiratory system, skin, and soft tissues, as well as for conditions
like endocarditis and osteomyelitis caused by methicillin-sensitive S. aureus. In Europe and
Australia, FLU is often recommended for treating staphylococcal infections and is the most
frequently prescribed oral antibiotic in the UK for this purpose.

When treating severe illnesses caused by resistant bacteria, FLU is preferred over
vancomycin. Due to this important factor, it is essential to examine the drug's key
characteristics and the methods currently used in the literature for identifying and measuring
this antimicrobial agent. The validation of analytical techniques ensures the quality control
measures are in place. Both the equipment and the materials used in the manufacturing
process are quality certified. Research on antimicrobial agents highlights the necessity to
develop and produce medications like FLU, which increases the demand for pharmaceutical
inputs and final products in laboratories and companies, as well as the accountability of the
quality control sector. 0% of your text is likely, the aim of quality control is to ensure the
health of the patient as well as the quality of the product.[7]

Flucloxacillin (FLU) is an antimicrobial agent that belongs to the semi-synthetic

isoxazolpenicillins group. It is resistant to penicillinase, an enzyme that breaks down the
beta-lactam ring, making other antibiotics ineffective against certain microbes. This paper
primarily discusses the form, structural modifications, mechanism of action,
pharmacodynamics, pharmacokinetics, and medicinal properties of FLU. Additionally, the
methods for analyzing FLU are outlined below.

STRUCTURAL FORM:

Flucloxacillin is available in two forms: magnesium octahydrate and flucloxacillin sodium

The form used in pharmaceutical formulations is flucloxacillin sodium
STRUCTURAL MODIFICATION:

FLU is classified as a semi-synthetic penicillin isoxazole. Its structure has been altered by
incorporating a bulky group in the lateral position (Figure 2), which serves as steric
hindrance and inhibits the action of beta lactamases. The synthesis of FLU is detailed in
Patent U.S.

MECHANISAM OF ACTION:

Antimicrobials can disrupt the formation of cell walls, hinder protein synthesis, interfere
with DNA synthesis, and obstruct metabolic processes. FLU is a bactericidal drug that
inhibits Gram-positive bacteria from forming their cell walls. By blocking the enzymes
known as transpeptidases, Penicillins typically prevent bacteria from multiplying.
Specifically, they inhibit the production of peptidoglycan. It's important to note that the
misuse of antibiotics has led to bacterial resistance, which has become a significant global
health concern.

Flucloxacillin

It binds to penicillin-binding proteins (PBs) on the bacterial cell membrane.

Inhibition of Peptidoglycan Cross-Linking

The inhibition leads to a weakened cell wall

Bacterial Cell Death

PHARMACOKINETICS AND PHARMACODYNAMICS:

FLU is utilized to treat infections caused by susceptible microorganisms; it has a
bioavailability of 50–70% after oral administration and is rapidly absorbed by the colon.
This medication can be administered orally, intravenously, intramuscularly, intrapleurally,
intraarticularly, or via nebulization. At 37°C in 0.15 M KCL, the organic compound FLU has
an acidic pKa of 2.76 in aqueous solution. The half-life of this substance is approximately
one hour. FLU is found in bone tissues, breast milk, pleural fluid, and synovial fluid, but it
does not easily disperse in cerebral fluid and can cross the placenta.

PHYSIOCHEMICAL PROPERTIES:

Fermentation results in FLU, a semi-synthetic compound that appears as a crystalline,

hygroscopic substance, typically white or nearly white. FLU is reported to be 96% soluble in
ethanol and highly soluble in water and methyl. The chemical name for FLU is (2S,5R,6R)-
3-(2-chloro-6-fluorophenyl)-6-[[3-] amino acid -5-methyl-1,2-oxazole-4-carbonyl] 1-
azabicyclo-3,3-dimethyl-7-oxo-4-thia [3.2.0] 2-carboxylic acid heptane. Its molecular weight
is 493.869 mol/L, and the chemical formula is C19H16ClFN3NaO5S.H2O. The pKa (acid)
is 3.75, and the LogP value is 2.58.

In this project we are formulating Flucloxacillin cream since cream preparation are
commercially not available additionally cream offer several advantages over solid dosage
form.

Topical medicines that can be applied to the skin are known as creams. These are viscous
liquids or semi-solid emulsions that can be either oil-in-water or water-in-oil types, with their
consistency varying based on the proportions of oil and water used. Creams serve both
medicinal and cosmetic purposes, including cleansing, beautifying, and enhancing
appearances. Their localized effect allows the active ingredients to penetrate the mucous
membrane or the deeper layers of the skin. These products are specifically designed for
topical application to improve the delivery of medication for skin disorders. Since creams are
formulated using techniques developed in the pharmaceutical industry, they are classified as
pharmaceutical products.

Creams, whether medicated or not, are commonly used to address dermatoses and various
skin conditions. People apply these creams as needed for their skin issues, which can be
herbal, ayurvedic, or allopathic in nature. They contain one or more active ingredients that
are mixed into a suitable base. Depending on their composition, creams can be classified as
either oil-in-water (o/w) or water-in-oil (w/o) emulsions. Historically, the term "cream" has
referred to semisolids that can be either water-in-oil, like cold cream, or oil-in-water, such as
vanishing cream.

ADVANTAGES:

The benefits of topical medication administration methods and their impact on patient care.
1. Targeted treatment

One of the most significant advantages of topical drug administration is its ability to provide
targeted treatment. Unlike oral medications that circulate throughout the body, topicals are
applied directly to the area needing attention. This precision reduces the risk of side effects
and enhances the therapeutic outcome by limiting the drug's exposure to healthy tissues.

2. Localized Effect

Topical medication administration excels at delivering localized effects. For instance, skin
conditions can be treated directly without affecting other bodily systems. This approach is
particularly beneficial when systemic absorption of a drug could lead to unwanted side
effects.

3. Reduced Systemic Side Effects

Topical medications significantly lower the risk of systemic side effects by bypassing the
digestive system and the liver's first-pass metabolism. This is especially beneficial for
patients who may be more sensitive to the adverse effects of systemic drugs.

4. Convenience and Ease of Use

Compared to oral medications, topical therapies are often more user-friendly for patients, as
they are generally easier to apply and require less frequent dosing. This can lead to better
adherence to prescribed treatment plans.

5. The Non-Invasive Route

The non-invasive aspect of topical drug delivery is particularly beneficial for individuals
who struggle with swallowing pills or have a fear of needles. This characteristic enhances
patient comfort and compliance.

6. Potential for controlled Release

Patches and other topical treatments offer controlled drug release over a set period. This
leads to less frequent dosing and a more stable medication level in the body, ensuring a
consistent therapeutic effect.

7. Suitability for Dermatological conditions

Topical administration is particularly effective for skin conditions. Medications for issues
like psoriasis, acne, and eczema often need to be applied directly to the affected areas.
Topical treatments provide a simple and effective way to address these concerns.

8. Suitable for Specific Population

Topical administration is versatile and suitable for various patient groups, including the
elderly and children. This approach is beneficial for individuals who may struggle with
traditional oral medications.
LITERATURE REVIEW:

Shivani Dattatray Khatal et.AL (2022) worked on the desire to look attractive has driven
people to rely on various beauty products to maintain youthfulness. In the realm of
cosmetics, herbal ingredients are widely used, and the market for herbal products, seen as
gifts from nature, is growing rapidly. Compared to chemical-based alternatives, herbal
cosmetics are considered safer due to their natural composition. The absence of harmful
synthetic substances in herbal formulations has garnered notable attention.

This study focused on developing and evaluating an antibacterial herbal vanishing cream
with natural ingredients. By utilizing carefully selected herbs, the formulation aimed to
address issues like premature aging, damage from radiation, pigmentation loss, lack of
moisture and nourishment, and acne. Tests were conducted to assess properties such as pH,
viscosity, spreadability, dilution, dye solubility, and antibacterial activity. The optimized
formulation (F4) was tested against *S. aureus*, a common cause of acne and contamination
in cosmetic products. Results showed that formulation F4 demonstrated superior
antibacterial activity, paving the way for further testing on performance and quality control.

Viola Strompfova et.AL (2024) worked on The urgent search for alternative antimicrobial
agents to address skin infections inspired an investigation into the inhibitory effects of eight
bioactive plant compounds—betulin, curcumin, glycyrrhizic acid, guaiazulene, piperine,
quercetin, quinine, and tannic acid. These were tested on 14 canine skin bacterial isolates (11
Gram-positive and 3 Gram-negative) chosen for their antibiotic resistance and virulence
traits. The minimum inhibitory concentration (MIC) and minimum bactericidal concentration
(MBC) were assessed using the broth microdilution technique.

The compounds displayed inhibitory activity ranging from 0.04 to over 16 mg/ml (MIC) and
from 0.25 to over 16 mg/ml (MBC). Tannic acid stood out as the most effective compound,
followed by quinine and curcumin, with *Bacillus cereus AE13* being the most sensitive
strain and *Enterococcus faecium AA14* the most resistant. A combination of tannic acid
and quinine in varying ratios (1:1, 1:2, 2:1) revealed the 1:2 ratio as the most effective.

This 1:2 mixture was used in creating different cream bases, with one formulation (cream F)
achieving an MIC of up to 63.0 mg/ml and a bacterial inactivation time of 1 to 6 hours
depending on the strain. The study highlights the strain-dependent antimicrobial potential of
plant-derived compounds against canine skin bacteria.

Mariana Nunes de Menezes et.AL (2018) worked on One increasing and concerning
element is bacterial resistance. The creation of novel medications and studies pertaining to
product quality control are frequently impacted by the high repeatability of these resistant
microbes. Flucloxacillin (FLU), one of the current antimicrobials, has bactericidal properties
and was created for oral and injection administration. Pharmaceutical formulations employ
the form of FLU sodium. It is an antibiotic that is resistant to penicillinase, an enzyme that
breaks down the beta-lactam ring of penicilins, rendering the medication ineffective. Both
qualitative and quantitative analyses are necessary to guarantee the population's health and
the quality of drugs. Effective and adequate quality control is crucial since only then can we
defeat microbial resistance. The features of FLU as a significant antibiotic and techniques for
identifying FLU in pharmaceutical products and biological matrices are the main focus of this
work. The most notable analytical technique for determining FLU among those discussed in
the literature HPLC. In any case, this process generates a lot of trash and employs lengthy
columns with toxic solvents (such acetonitrile) that give extended runs. Nowadays, creating
sustainable, environmentally responsible, and ecologically right methods has taken
precedence. This fresh perspective on analytical techniques ought to be applied to FLU
analyses in order to advance and enhance current techniques.

Nasser H. Mohammad et.AL (2022) worked on The development of a perfect biopolymer

with distinct mechanical and physicochemical properties that complement its applications in
several fields, including fuel cell membranes, wound dressing, and food packaging, is
critically needed. The intriguing physicochemical characteristics of bacterial cellulose (BC),
including its high crystallinity, water-holding capacity, mechanical stability, purity,
biodegradability, and biocompatibility, as well as its nanofiber structure, make it a promising
biopolymer. The low yield of BC is one among the issues that restricted its industrial
manufacturing. To take advantage of its many applications in food and medicine, a high-
producing strain of this highly physicochemical biopolymer is required. Strawberry was used
to isolate the bacterial cellulose (BC) synthesizing Komagataeibacter hansenii S strain. The
isolate was identified as Komagataeibacter hansenii S because its 16S rDNA sequence
homology with Komagataeibacter hansenii strain LMG 1527 was 99%. The isolated strain
was chosen because, under ideal culturing circumstances, it had a high production yield of
5.4±0.6 g/l, dry weight. SEM, FTIR, XRD, TG, and mechanical tests were used to examine
the morphological and physicochemical characteristics of the generated BC. The three-
dimensional porous nanofiber structure was revealed by FESEM. FTIR and XRD verified
BC's structure. TG demonstrated the BC's good mechanical qualities and thermal stability.
BC nanofibers impregnated with amoxicillin/Flucloxacillin shown strong antibacterial
activity against both Gram-positive and Gram-negative bacteria. The mechanical and
physicochemical characteristics of BC generated by Komagataeibacter hansenii S suggest
that it may be used in fuel cell membranes, wound dressings, and food packaging.

S. E. OKAFO et.AL (2019) worked on Plant-based antibiotics offer a wide range of possible
medical uses. In addition to effectively treating infectious infections, they also lessen some of
the side effects that are frequently connected to synthetic antibiotics. The purpose of this
study was to create a topical cream formulation using an ethanol extract of Vernonia ambigua
and examine its antibacterial properties.The dried leaves were macerated to create an ethanol
extract, and the filtrate was then dried out by concentration. As test organisms, Escherichia
coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans were used to
assess its antibacterial activity. A cream containing the ethanol extract was created, and its
physicochemical and antibacterial qualities were assessed.15.38% w/w was the percentage
yield for the ethanol extraction. The cream formulations had a pH range of 4.56 to 6.89 and a
viscosity range of 16500 to 51300 mPas. Every cream formulation was steady. Although the
three bacteria's zones of inhibition varied significantly, they were all susceptible to the
ethanol extract and the cream formulations. Candida albicans was not effectively combated
by the ethanol extract. For E. coli, P. aeruginosa, and S. aureus, the ethanol extract's
minimum inhibitory concentration (MIC) was 100 mg/mL, 100 mg/mL, and 12.5 mg/mL,
respectively.
The investigation showed that both the ethanol extract and the cream formulation had
antibacterial qualities, and that the extract's activity did not decrease when it was turned into a
cream.
Somayeh Handali, BSc et.AL(2010) worked on Because of its anti-dysentery and anti-
diarrheal properties as well as its usage in treating skin conditions, Oxalis corniculata is well
known. The purpose of this study was to create a herbal antibacterial cream and assess the
antibacterial activity of O. corniculata aqueous extract on Escherichia coli and
Staphylococcus aureus species. The antibacterial activity of the O. corniculata extract was
evaluated using the disk diffusion method. This plant's antibacterial properties were evaluated
in comparison to those of nalidixic acid, carbeincillin, streptomycin, chloramphenicol, and
doxycycline. Different amounts of ingredients were combined to make the cream, and then
the necessary quantity of the herbal extract was added. The physical and chemical stability of
the cream compositions were compared. Finally, by changing the type and the formulation
facter, the optimal formulation was chosen.

The findings demonstrated that O. corniculata's aqueous extract was efficient against S.
aureus and E. coli, and that the antibacterial activity increased with extract concentration.
During the three-month storage period, control tests and stability analysis revealed a steady,
uniform appearance with no separation phase. O. corniculata's aqueous extract demonstrated
potent antibacterial activity, particularly as the extract concentration rose. The formulation
might be applied topically to shield skin from harm caused by S. aureus and E. coli,
according to the findings of several chemical and physical testing of the cream. According to
the findings of this investigation, this plant is a good candidate for more pharmacological
testing.

Ankit Singh Chauhan et.AL (2023) worked on Skin infections typically and frequently
provide therapeutic problems to researchers and practitioners because of the growing worry
about bacterial, viral, and fungal strains that are resistant to many drugs. Both copper and
zinc sulfate have well-established antibacterial qualities that have been studied for many
years. Nevertheless, topical formulations such as gels and creams have not assessed the
synergistic action of both metal ions as antibacterial agents. The current study's objective is to
create creams and gels with copper and zinc either separately or in combination, then assess
the metal ions' in vitro antibacterial effectiveness. In creams and gels, zinc sulfate and copper
sulfate demonstrated substantial synergistic antibacterial action. It is confirmed that the metal
gel and cream increase the antibacterial activity by analyzing a number of factors, including
pH, spreadability, viscosity, and antibacterial qualities. The combined in-vitro antibacterial
activity of copper and zinc sulfate in creams and gels was assessed and validated in this
study.

S, Sakthi Priyadarshini et.AL. (2021) worked on Formulation and evaluation of herbal

antibacterial cream from ethyl acetate extract of leaves of Spinacia oleracea linn. against
Aeromonas skin and soft tissue infections.Skin and soft tissue infections still remains a major
challenge in assessing the etiological and severity conditions. The rapid onset of cellulites in
the setting of soft tissue trauma and exposure to water results in the possibility of infection
with this organism. Here the active ethyl acetate extract was formulated into a suitable herbal
cream and evaluated for its physical, chemical and stability parameters.

Somayeh Handali Bsc et.Al.(2022) worked on Formulation and evaluation of antibacterial

cream from oxalis corniculata aqueous extract.Oxalis corniculata is well known because of its
anti dysentery and antidiarrheal effects and also its application in skin diseases. The aim of
this study was to evaluate the antibacterial activity of aqueous extract of O. corniculate on
staphylococcus aureus and Escherichia coli species and to formulate a herbal antibacterial
cream.

Mei x.Chen et.Al.(2020) worked on Formulation and evaluation of antibacterial creams and
gels containing metal ions for topical application.Skin infections occur commonly and often
present therapeutic challenges to practitioners due to the growing concerns regarding
multidrug resistant bacterial, viral, and fungal strains. The antimicrobial properties of zinc
sulphate and copper sulphate are well known and have been investigated for many years.
However the synergistic activity between these two metal ions as antimicrobial ingredients
has not been evaluated in topical formulations.

R.Rahmad et.AL.(2019) worked on Antibacterial cream formulation of ethanolic pliek U

extracts and ethanolic residue hexane pliek U extracts against staphylococcus aureus.Pliek U
is a fermented crude coconut meat has been used as traditional medicinal plants. Traditional
food and also used as traditional topical medicine in ache. Pliek U is potential as a source of
free fatty acids such as lauric acid and mono lauric acid which have anti bacterial properties.
The aim of this study is to determine the activity ethanolic pliek U extracts and ethanolic of
residue hexane of Pliek U extracts and also the activities of their cream formulation against
staphylococcus aureus. The antibacterial activity was determined by disc diffusion method
with clindamycin as a positive control.
Mahendran sekar et.Al.(2017) worked on Formulation and evaluation of novel antibacterial
and anti inflammatory cream containing muntingia calabura leaves extract.The main
objective of the study was to formulate anti bacterial and anti inflammatory cream using
muntingia calabura leaves extract. The antibacterial activity of methanolic extract was studied
in different concentrations (5,10 and 25 mg/ml) and the formulated cream was studied in the
concentration of (10,25,50 and 100 mg/ml). The results showed that the formulated cream
can be used for bacterial infections and to reduce inflammation.

Vinaya Kizhakkepatt Kizhakkekalam et.al.(2019) worked on Antibacterial and wound

healing potential of topical formulation pf marine symbiotic bacillus.The present study
evaluated an antibacterial and wound healing topical formulation prepared with the ethyl
acetate extract of marine symbiotic bacillus amyloliquefaciens MTTC 12716 as the basic
ingredient and the grafted macroalgalpolysaccharide as the gel base with an appropriate
proportion of natural stabilizing agents. The formulation exhibited potent antibacterial
activities against clinical isolates of staphylococcus aureus and pseudomonas aeruginosa
causing infection compared with commercially available antimicrobial cream clindamycin.
The stability studies showed that the formulation maintained its physicochemical
characteristics and minimal growth of bacteria on the plates throughout the time period of 18
months This study has established the antibacterial and wound healing potential of a topical
formulation of marine symbiotic B. amyloliquefaciens.

Satpute Kl et. Al.(2019) said that both inflammatory and non-inflammatory lesions are
characteristics of acne. Acne lesions are caused by a variety of pathophysiological reasons,
including hormonal, bacterial, and immunological ones. It has been established that
Propionibacterium acnes and Staphylococcus epidermidis are pus-forming bacteria that cause
acne inflammation. The creation and assessment of a herbal cream against this acne vulgaris
etiologic agent is the focus of the current study. After being separated, the boswellia oil was
combined to create a topical lotion. Using the agar well diffusion method, in vitro
antibacterial activity was assessed against P. acnes, S. epidermidis, and S. aureus. The
produced formulations' measured zones of inhibition were contrasted with those of a
commercially available topical herbal formulation and a conventional antibiotic
(Clindamycin). The produced creams were tested for in vitro diffusion, drug content,
stability, spreadability, pH, and viscosity. Boswellia oil herbal compositions would suppress
the development of P. acnes and S. epidermidis, according to the results of the agar well
diffusion, and creams exhibited significant antimicrobial efficacy against these bacteria in
comparison to standard.

Chauhan Lalita et.AL.(2020) Because they are so simple to apply and remove from the skin,
creams have long been regarded as a crucial component of cosmetic products as topical
therapies. Pharmaceutical creams can be used for many cosmetic purposes, including
cleaning, beautifying, changing appearance, hydrating, and protecting the skin from bacterial
and fungal infections. They can also be used to treat cuts, burns, and wounds. The general
population and society can safely employ these semi-solid preparations. Despite its
propensity for self-healing, human skin is susceptible to damage. However, infection is a
possibility, particularly in the early stages of injury, and the natural healing process can take
some time. Medicated creams can be administered to the injury site in certain situations to
hasten the healing process and prevent infection. This review focuses on the use of topical
drug delivery systems, such as pharmaceutical creams, for wound healing. It includes a
thorough discussion of the wound healing process, appropriate cream preparation techniques,
cream classification according to function, benefits and drawbacks, and the different types of
creams, ingredients used in their formulation, and evaluation parameters.

Yashwant Singh Jat et.AL.(2023) A drug delivery system seeks to increase patient acceptance
and compliance in addition to getting the medication into the body. Topical agents can be
delivered in the following dose forms: ointment, paste, lotion, moisturizing lotion, and
powder. But because of their qualities, lotion is better. The goal of current research is to
create gel using rice bran wax. The vegetable wax that is separated from rice bran oil is
known as rice bran wax. Wax typically makes around 2–6% of the oil. On average,
nevertheless, it is thought to contain 3% wax. Globule size, the assessment of lotion products'
inherent viscosity, and homogeneity are examples of physicochemical tests that have
historically been employed to offer plausible proof of reliable product performance. But for
the sake of these investigations, the finished lotion products were evaluated utilizing
conventional protocol for their clarity, pH, viscosity, spreadability, skin irritation test, and in
vitro diffusion experiments. Every result complies with the official requirements.
AIM: To formulate and evaluate antibacterial Flucloxacillin cream

OBJECTIVES:

1. BCS Classification: Flucloxacillin, as a BCS Class II drug, indeed has low solubility and
high permeability. This classification emphasizes the need for solubility enhancement to
improve its bioavailability.
2. Solubility Enhancement: Formulating Flucloxacillin as a cream is a practical approach.
Techniques like using solubilizing agents, co-solvents, or surfactants can be explored to
enhance its solubility
3. Antibacterial Efficacy: To evaluate the cream's antibacterial activity, methods like agar
diffusion, broth dilution, or time-kill assays can be employed. These tests will help
determine its effectiveness against pathogens like Staphylococcus aureus and Escherichia
coli4.
4. Stability Studies: Conducting stability studies under ICH guidelines is crucial. This
includes accelerated and long-term testing to assess the cream's shelf life, physical
stability, and chemical integrity6.
5. Skin Compatibility: Patch tests, cumulative irritation tests, and sensitization studies are
essential to ensure the cream's safety for topical use. These tests will help evaluate
potential irritation or allergic reactions8.
6. Excipients Selection: Choosing suitable excipients like emulsifiers, stabilizers, and
preservatives is vital for creating a stable and effective formulation. Ensure compatibility
with Flucloxacillin and the cream's intended use.
7. Physicochemical Properties: Assessing properties like pH, viscosity, spreadability, and
homogeneity is critical for quality control. These parameters ensure the cream's usability
and consistency10.