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QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design

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@qbd-lurasidone-solid-lipid-nanoparticles-box-behnkenUpdated Oct 2026

QTPP, risk assessment, 17 Design-Expert runs, a design space and a rat PK study — a full M.Pharm research-work plan

M.Pharm, Pharmaceutics · Sem 4 · Advanced · 26 weeks · Solo

More info
Degree
Master of Pharmacy
Branch
Pharmaceutics
Level
Advanced · 26 weeks · Solo
Relevant for
All India
Common at
PCI (M.Pharm 2014 scheme), RGUHS, JNTUH
Syllabus
PCI 2014 semester scheme · MPH 402P / MPH 403P Research Work / Colloquium + Final Presentation · Semester 4
Tech stack
  • Design-Expert (Box–Behnken design, ANOVA, desirability)
  • Hot homogenisation + probe sonication
  • Zetasizer (DLS size, PDI, zeta potential)
  • UV-Visible spectrophotometry / RP-HPLC
  • DSC, FTIR, PXRD, TEM
  • Dialysis-bag in-vitro release
  • Phoenix WinNonlin (non-compartmental PK)
  • GraphPad Prism
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  1. Pinned

    QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design

    @qbd-lurasidone-solid-lipid-nanoparticles-box-behnken

    1 min

    Overview

    This M.Pharm Pharmaceutics research work applies Quality by Design (QbD) to develop solid lipid nanoparticles (SLNs) of lurasidone hydrochloride, an atypical antipsychotic used in schizophrenia and bipolar depression. Lurasidone is a BCS class II drug with very low aqueous solubility, extensive first-pass metabolism by CYP3A4 and a low, food-dependent oral bioavailability — patients are told to take it with a meal of at least 350 kcal. A lipid nanocarrier can improve solubilisation, promote lymphatic uptake and reduce this food effect.

    The work follows the ICH Q8(R2) pathway: a Quality Target Product Profile (QTPP), identification of critical quality attributes (CQAs), an Ishikawa diagram and risk-estimation matrix, screening of lipids and surfactants, and a three-factor, three-level Box–Behnken design in Design-Expert with lipid amount, surfactant concentration and sonication time as factors and particle size, entrapment efficiency and 12-hour cumulative release as responses. The design space and a desirability-based optimised batch are then verified experimentally.

    The optimised SLNs are characterised by DLS, zeta potential, TEM, DSC, FTIR and PXRD, tested for in-vitro release and ICH stability, and evaluated in a single-dose oral pharmacokinetic study in Wistar rats after IAEC approval, with parameters calculated in Phoenix WinNonlin. Both software tools are named in the PCI M.Pharm syllabus, and the plan maps directly onto the MPH 304P → MPH 402P/403P research-work slots.

    Syllabus alignment

    PCI · 2014 semester scheme

    MPH 402P / MPH 403P · Research Work / Colloquium + Final Presentation · Semester 4 · 19 credits · dissertation 500 (objectives 50, methodology 150, results & discussion 250, conclusions 50) + presentation 250 (100 + 50 + Q&A 100)

    Subjects this project applies
    • MPH 103T Modern Pharmaceutics (optimisation techniques)
    • MPH 201T Molecular Pharmaceutics (nano-based drug delivery)
    • MPH 202T Advanced Biopharmaceutics and Pharmacokinetics
    • MRM 301T Research Methodology and Biostatistics
    How it is evaluated

    dissertation ≥ 75 typed pages, bound, quadruplicate; chapters: Introduction, Aims/Objectives, Review, Materials & Methods, Results, Discussion, Conclusion, Summary, References, Annexures; RGUHS: synopsis within 9 months of admission, dissertation ≥ 2 months before exam

    15 Unlock

    1 min read · 15 viva questions

  2. QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design

    @qbd-lurasidone-solid-lipid-nanoparticles-box-behnken

    2 min

    Synopsis

    Abstract

    Lurasidone hydrochloride SLNs will be prepared by hot homogenisation followed by probe sonication using a lipid and surfactant selected by solubility and screening studies. A Box–Behnken design (3 factors, 3 levels, 17 runs including 5 centre points) will be used to study the effect of lipid amount (X1), surfactant concentration (X2) and sonication time (X3) on particle size (Y1), entrapment efficiency (Y2) and cumulative drug release at 12 h (Y3). The optimised formulation will be characterised, tested for stability, and its oral pharmacokinetics compared with a drug suspension in rats.

    Introduction

    Lipid nanocarriers such as SLNs combine the physical stability of a solid matrix with the biocompatibility of physiological lipids. For lipophilic drugs they can increase apparent solubility, protect the drug and promote chylomicron-mediated lymphatic transport, which partly bypasses hepatic first-pass metabolism. QbD replaces one-factor-at-a-time trial and error with a systematic, risk-based and statistically designed approach that regulators encourage.

    Review and research gap

    Published work on lurasidone delivery covers solid dispersions, nanosuspensions, self-nanoemulsifying systems and some lipid carriers. Fewer reports combine a documented QTPP and risk assessment with a response-surface design, an experimentally verified design space and in-vivo PK in one study. This work addresses that gap within the scope of an M.Pharm dissertation.

    Hypothesis

    An optimised SLN formulation will give particle size below 200 nm, entrapment efficiency above 75% and significantly higher Cmax and AUC0–t than a plain drug suspension in rats.

    Feasibility

    • Technical: probe sonicator, Zetasizer, UV/HPLC, DSC and FTIR are available in the department or a central instrumentation facility; TEM and PXRD through a university sophisticated-instrument facility.
    • Software: Design-Expert and WinNonlin (trial or institutional licence) and GraphPad Prism.
    • Ethical: IAEC approval under CPCSEA guidelines before the animal study.
    • Time: screening and design in Semester III; optimisation, characterisation and PK in Semester IV.
  3. QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design

    @qbd-lurasidone-solid-lipid-nanoparticles-box-behnken

    1 min

    Problem statement

    Lurasidone hydrochloride has poor aqueous solubility, high first-pass metabolism and an oral bioavailability that depends strongly on food, which complicates dosing and adherence in patients with schizophrenia or bipolar depression. Conventional tablets cannot overcome these limitations.

    Lipid nanocarriers are a rational approach, but formulation outcomes such as particle size, entrapment and release depend on several interacting process and material variables. Optimising them one factor at a time is slow, misses interactions and gives no defined design space. There is therefore a need to develop lurasidone SLNs through a systematic QbD approach — defining the QTPP and CQAs, assessing risk, using a Box–Behnken response-surface design to model the effect of critical variables, establishing and verifying a design space — and to confirm that the optimised formulation improves oral pharmacokinetics compared with a conventional suspension.

  4. QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design

    @qbd-lurasidone-solid-lipid-nanoparticles-box-behnken

    1 min

    Objectives & scope

    1. 01Define the QTPP and CQAs and perform an initial risk assessment with an Ishikawa diagram and risk-estimation matrix.
    2. 02Carry out preformulation: drug identification, solubility in solid lipids and surfactants, and drug–excipient compatibility by FTIR and DSC.
    3. 03Develop and validate a UV or RP-HPLC analytical method for lurasidone as per ICH Q2(R1).
    4. 04Optimise SLNs using a three-factor Box–Behnken design in Design-Expert and establish a design space with desirability-based optimisation.
    5. 05Characterise the optimised SLNs for size, PDI, zeta potential, morphology, crystallinity and in-vitro release kinetics.
    6. 06Evaluate stability of the optimised formulation under ICH Q1A(R2) conditions.
    7. 07Compare oral pharmacokinetics of the optimised SLNs with a drug suspension in Wistar rats using non-compartmental analysis in WinNonlin.

    Scope

    In scope

    • QbD elements: QTPP, CQAs, risk assessment, Box–Behnken design, design space, verification batches.
    • Laboratory-scale SLN preparation, full physicochemical characterisation and in-vitro release.
    • Three-month ICH stability (refrigerated and room-temperature conditions) of the optimised batch.
    • Single-dose oral PK in rats after IAEC approval.

    Out of scope

    • Pharmacodynamic behavioural models, toxicity studies and human studies.
    • Scale-up beyond laboratory batches and freeze-drying process optimisation.
    • Brain-targeting via intranasal route (listed as future scope).
  5. QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design

    @qbd-lurasidone-solid-lipid-nanoparticles-box-behnken

    2 min

    Methodology

    Research design: experimental, formulation-development study using the QbD framework of ICH Q8(R2), Q9 and Q10, with a response-surface design and an animal pharmacokinetic comparison.

    Phase I (Semester III, MPH 304P)

    1. Literature review, QTPP and CQA table, Ishikawa diagram, risk-estimation matrix (low / medium / high).
    2. Preformulation: melting point, λmax, solubility of drug in solid lipids (glyceryl monostearate, Compritol 888 ATO, Precirol ATO 5, stearic acid) and surfactants (Poloxamer 188, Tween 80); FTIR and DSC compatibility.
    3. Analytical method validation (linearity, accuracy, precision, LOD, LOQ).
    4. Preliminary trials to fix factor ranges.

    Phase II (Semester IV, MPH 402P) 5. Box–Behnken design: X1 lipid amount (e.g. 100–300 mg), X2 surfactant concentration (1–3% w/v), X3 sonication time (3–9 min); 17 runs with 5 centre points; responses Y1 particle size, Y2 entrapment efficiency, Y3 release at 12 h. 6. Model fitting (linear, 2FI, quadratic), ANOVA, lack-of-fit, adjusted and predicted R², 3-D response-surface and contour plots, overlay plot for design space, desirability function. 7. Prepare three verification batches; accept if percentage prediction error is within ±5–10%. 8. Characterise: DLS size/PDI/zeta, TEM, DSC, PXRD, FTIR, EE by ultracentrifugation, in-vitro release by dialysis bag in 0.1 N HCl (2 h) then phosphate buffer pH 6.8; fit zero-order, first-order, Higuchi and Korsmeyer–Peppas models. 9. Stability at 5 ± 3 °C and 25 ± 2 °C / 60 ± 5% RH for 3 months. 10. PK study: Wistar rats (n = 6 per group, justified by resource-equation method and CPCSEA reduction principle), SLN vs suspension, oral single dose, serial blood sampling to 24 h, plasma analysis by validated HPLC, non-compartmental analysis in WinNonlin (Cmax, Tmax, AUC0–t, AUC0–∞, t½, relative bioavailability).

    Statistics: Design-Expert ANOVA (p < 0.05) for models; GraphPad Prism unpaired t-test for PK parameters between groups; results as mean ± SD.

    Ethics: IAEC approval under CPCSEA before any animal work; drug gift sample documentation and laboratory waste disposal as per institutional SOP.

  6. QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design

    @qbd-lurasidone-solid-lipid-nanoparticles-box-behnken

    1 min

    Architecture & tech stack

    • Design-Expert (Box–Behnken design, ANOVA, desirability)
    • Hot homogenisation + probe sonication
    • Zetasizer (DLS size, PDI, zeta potential)
    • UV-Visible spectrophotometry / RP-HPLC
    • DSC, FTIR, PXRD, TEM
    • Dialysis-bag in-vitro release
    • Phoenix WinNonlin (non-compartmental PK)
    • GraphPad Prism

    The study is organised around the QbD cycle: define quality, identify risks, model the process statistically, fix a design space and verify it, then prove the benefit in vivo.

    flowchart TD
  A[QTPP: oral SLN, size below 200 nm, EE above 75%] --> B[CQAs: size, PDI, zeta, EE, release]
  B --> C[Risk assessment: Ishikawa and risk matrix]
  C --> D[Preformulation and lipid/surfactant screening]
  D --> E[Analytical method validation ICH Q2]
  E --> F[Box-Behnken design: 3 factors, 17 runs]
  F --> G[Prepare runs: hot homogenisation and probe sonication]
  G --> H[Measure Y1 size, Y2 EE, Y3 release at 12 h]
  H --> I[Model fitting and ANOVA in Design-Expert]
  I --> J[Design space and desirability optimum]
  J --> K{Verification batches within prediction error?}
  K -->|No| I
  K -->|Yes| L[Characterisation: TEM, DSC, PXRD, FTIR, release kinetics]
  L --> M[ICH stability 3 months]
  L --> N[IAEC-approved rat PK study]
  N --> O[WinNonlin non-compartmental analysis]
  M --> P[Dissertation and final presentation]
  O --> P

    QTPP (extract)

    ElementTargetJustification
    Dosage formOral SLN dispersionLymphatic uptake, food-effect reduction
    Particle size< 200 nm, PDI < 0.3Uptake by enterocytes and M cells
    Zeta potential≥ ±20 mV (with steric stabiliser)Physical stability
    Entrapment> 75%Dose delivery
    ReleaseSustained over 12–24 hReduced peak-related effects
  7. QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design

    @qbd-lurasidone-solid-lipid-nanoparticles-box-behnken

    5 modules

    Modules

    • QbD definition and risk assessment

      Prepare the QTPP and CQA tables with justifications, draw the Ishikawa diagram of material, method and machine variables, and rank risks in a risk-estimation matrix to select the three factors for the design.

    • Preformulation and analytical validation

      Confirm drug identity, determine solubility in candidate lipids and surfactants, check compatibility by FTIR and DSC, and validate a UV or RP-HPLC method for linearity, accuracy, precision, LOD and LOQ as per ICH Q2(R1).

    • Box–Behnken optimisation in Design-Expert

      Run the 17 formulations, enter responses, select the best-fitting polynomial model for each response using ANOVA and lack-of-fit, interpret coefficients and contour plots, and derive the design space and optimum with the desirability function.

    • Characterisation and stability

      Characterise the optimised batch by DLS, zeta potential, TEM, DSC, PXRD and FTIR, study in-vitro release with kinetic model fitting, and monitor size, EE and drug content over three months of ICH storage.

    • Pharmacokinetic evaluation

      Obtain IAEC approval, dose rats with SLN or suspension, collect serial plasma samples, quantify lurasidone with a bioanalytical HPLC method and calculate PK parameters and relative bioavailability in Phoenix WinNonlin.

  8. QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design

    @qbd-lurasidone-solid-lipid-nanoparticles-box-behnken

    Locked

    Presentation

    12 slides with speaker notes. The outline below is free; the bullets, notes and the generated .pptx unlock with the project.

    1. QbD-Based Lurasidone Solid Lipid Nanoparticles
    2. Introduction and Rationale
    3. Review of Literature and Gap
    4. Aim, Objectives and Plan of Work
    5. QTPP, CQAs and Risk Assessment
    6. Preformulation and Analytical Method
    7. Box–Behnken Design
    8. Model Fitting and Response Surfaces
    9. Design Space and Verification
    10. Characterisation and Stability
    11. Pharmacokinetic Study
    12. Conclusion and Future Scope

    Bullets, speaker notes and the .pptx download unlock with the project.

    Presentation is locked: 12 slides, Speaker notes, .pptx download.

    Unlock for ₹2,000
  9. QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design

    @qbd-lurasidone-solid-lipid-nanoparticles-box-behnken

    Locked

    How to run

    A research, analysis or design project, so there's no code bundle: 11 steps to carry it out with Design-Expert (Box–Behnken design, ANOVA, desirability), Hot homogenisation + probe sonication and Zetasizer (DLS size, PDI, zeta potential).

    The good part is behind this lock. Like every good viva answer.

    How to run is locked: 11 steps.

    Unlock for ₹2,000
  12. QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design

    @qbd-lurasidone-solid-lipid-nanoparticles-box-behnken

    1 min

    Future scope

    • Nanostructured lipid carriers (NLCs) with a liquid lipid to increase loading and reduce expulsion on storage.
    • Intranasal SLN or NLC formulation for nose-to-brain delivery with brain-to-plasma ratio studies.
    • Lymphatic-transport confirmation using cycloheximide-treated rats.
    • Freeze-drying with cryoprotectant screening and reconstitution studies.
    • Pharmacodynamic evaluation in a validated behavioural model after IAEC approval.
    • In-vitro–in-vivo correlation and scale-up with process analytical technology.
  13. QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design

    @qbd-lurasidone-solid-lipid-nanoparticles-box-behnken

    7 sources

    References

    1. ICH Q8(R2) Pharmaceutical Development; Q9 Quality Risk Management; Q10 Pharmaceutical Quality System; Q2(R1) Validation of Analytical Procedures; Q1A(R2) Stability Testing
    2. Pharmacy Council of India — M.Pharm Syllabus and Regulations (research-work evaluation scheme)
    3. Müller RH, Mäder K, Gohla S. Solid lipid nanoparticles (SLN) for controlled drug delivery — a review of the state of the art. Eur J Pharm Biopharm. 2000;50(1):161–177.
    4. Montgomery DC. Design and Analysis of Experiments. 9th ed. Wiley.
    5. Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) guidelines for laboratory animal facility. Ministry of Fisheries, Animal Husbandry and Dairying, Government of India.
    6. Shargel L, Yu ABC. Applied Biopharmaceutics and Pharmacokinetics. 7th ed. McGraw-Hill.
    7. Jain NK. Advances in Controlled and Novel Drug Delivery. CBS Publishers.

    Cite this bundle

    OnlyProjects. (2026). QbD-Based Development of Lurasidone Hydrochloride Solid Lipid Nanoparticles Using a Box–Behnken Design: M.Pharm Pharmaceutics project bundle [Educational resource]. https://onlyprojects.online/projects/mpharm-pharmaceutics-qbd-lurasidone-solid-lipid-nanoparticles-box-behnken

Slides, diagrams & files

12 slides. Titles are free; bullets, speaker notes and the .pptx unlock with the project.

  1. SLIDE 1

    QbD-Based Lurasidone Solid Lipid Nanoparticles

  2. SLIDE 2

    Introduction and Rationale

  3. SLIDE 3

    Review of Literature and Gap

  4. SLIDE 4

    Aim, Objectives and Plan of Work

  5. SLIDE 5

    QTPP, CQAs and Risk Assessment

  6. SLIDE 6

    Preformulation and Analytical Method

  7. SLIDE 7

    Box–Behnken Design

  8. SLIDE 8

    Model Fitting and Response Surfaces

  9. SLIDE 9

    Design Space and Verification

  10. SLIDE 10

    Characterisation and Stability

  11. SLIDE 11

    Pharmacokinetic Study

  12. SLIDE 12

    Conclusion and Future Scope

Architecture diagram

1
flowchart TD
  A[QTPP: oral SLN, size below 200 nm, EE above 75%] --> B[CQAs: size, PDI, zeta, EE, release]
  B --> C[Risk assessment: Ishikawa and risk matrix]
  C --> D[Preformulation and lipid/surfactant screening]
  D --> E[Analytical method validation ICH Q2]
  E --> F[Box-Behnken design: 3 factors, 17 runs]
  F --> G[Prepare runs: hot homogenisation and probe sonication]
  G --> H[Measure Y1 size, Y2 EE, Y3 release at 12 h]
  H --> I[Model fitting and ANOVA in Design-Expert]
  I --> J[Design space and desirability optimum]
  J --> K{Verification batches within prediction error?}
  K -->|No| I
  K -->|Yes| L[Characterisation: TEM, DSC, PXRD, FTIR, release kinetics]
  L --> M[ICH stability 3 months]
  L --> N[IAEC-approved rat PK study]
  N --> O[WinNonlin non-compartmental analysis]
  M --> P[Dissertation and final presentation]
  O --> P

Files

Viva questions & answers

3 of 15 questions free. Explain each answer in your own words before you move on.

  1. Concept

    What is Quality by Design and how is it different from traditional development?

    QbD, described in ICH Q8(R2), is a systematic approach that begins with predefined objectives and emphasises product and process understanding based on sound science and quality risk management. Traditional development tests one factor at a time and checks quality at the end; QbD builds quality in by identifying critical variables, modelling their effects and defining a design space.

  2. Concept

    Define QTPP, CQA and design space.

    The QTPP is a prospective summary of the quality characteristics the product should have. CQAs are physical, chemical or biological properties that must stay within limits to assure quality, such as particle size and entrapment. The design space is the multidimensional combination of input variables shown to provide assurance of quality; working within it is not considered a change.

  3. Concept

    How can SLNs improve the oral bioavailability of lurasidone?

    SLNs keep the drug solubilised in a lipid matrix, increase surface area, protect it in the gut, and lipid digestion products promote chylomicron formation and lymphatic transport, which partly bypasses hepatic first-pass metabolism by CYP3A4. They may also reduce the food effect because the formulation supplies its own lipid.

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